Philips FDA Device Footprint: Clearances, Recalls & Consent Decree
A comprehensive regulatory dossier analyzing Philips' FDA clearances, cardiovascular PMA distribution, recall history under the 2024 consent decree, and global manufacturing plants.
Executive Summary
What does the FDA database reveal about Philips' medical device clearance history, recalls, and manufacturing footprint?
Philips and its subsidiaries (including Respironics, Volcano, and Spectranetics) hold 1,322 active 510(k) clearances and 350 PMA approvals or supplements. The company's 510(k) portfolio is dominated by Radiology (654 clearances, or 49.47%), Cardiovascular (327 clearances, or 24.74%), and Anesthesiology (217 clearances, or 16.41%) specialties. Its clearances are led by magnetic resonance imaging scanners (product code LNH, 125 clearances) and non-continuous ventilators (product code BZD, 79 clearances). In the high-risk PMA sector, Philips' portfolio is focused on cardiovascular interventions, led by coronary laser angioplasty systems (product code LPC, 124 filings).
However, Philips has faced significant regulatory challenges, with 2,397 FDA-registered recalls. While its computed tomography (product code JAK, 396 recalls) and MRI scanners (product code LNH, 343 recalls) represent high recall counts, its sleep and respiratory division (Respironics) remains under a strict April 2024 FDA Consent Decree. Geographically, Philips operates a global network, with primary registered facilities in Mississauga, Canada (1,177 listings), Boeblingen, Germany (593 listings), and Best, Netherlands (445 listings).
Philips FDA Footprint at a Glance
- 510(k) clearances: 1,322 (Radiology 654 / Cardiovascular 327 / Anesthesiology 217)
- PMA approvals and supplements: 350 (led by laser angioplasty LPC — 124)
- FDA-registered recalls: 2,397 (led by CT JAK — 396, MRI LNH — 343) — inflated by Respironics
- Establishment / device listings: 5,180 (Mississauga, Boeblingen, Best lead)
- Defining regulatory event: April 9, 2024 consent decree restricting new CPAP/BiPAP sales in the U.S.
- 2026 field action: May 2026 Class II cooling-hose recall on Allura and Azurion interventional systems
Introduction: The Dual Regulatory Profile of Philips
Royal Philips, a Dutch multinational conglomerate, has transitioned over the last decade into a pure-play health technology developer. The company's portfolio spans three core areas: Diagnosis & Treatment (precision medicine, ultrasound, and image-guided therapy), Connected Care (monitoring, therapeutic care, and sleep/respiratory care), and Personal Health. A series of strategic acquisitions — Volcano in 2015, Spectranetics in 2017 — and the protracted Respironics recall have together reshaped which parts of Philips' portfolio carry the most regulatory weight, making a database-level view more useful than the corporate segment labels alone.
For hospital procurement boards, risk managers, and regulatory affairs (RA) professionals, evaluating Philips requires analyzing a dual regulatory profile:
- The High-Performing Imaging & Cardiovascular Portfolio: Led by market-leading ultrasound systems, computed tomography (CT), magnetic resonance imaging (MRI), and image-guided cardiovascular therapy systems (expanded through acquisitions like Volcano and Spectranetics).
- The High-Risk Sleep & Respiratory Care Portfolio: Managed under its Philips Respironics subsidiary, which has been the subject of one of the largest medical device recalls in history and operates under an active federal consent decree.
This dossier provides a data-driven breakdown of Philips' FDA database footprint. By mining and cross-referencing datasets from the FDA 510(k) database, Premarket Approval (PMA) registry, Medical Device Recalls database, and Establishment Registration database, we detail the clinical specialties, product codes, recall histories, and global manufacturing sites that shape Philips' regulatory footprint.
How These Numbers Were Computed
The figures in this dossier are aggregates computed from four public FDA datasets extracted in June 2026: the 510(k) database, the PMA database, the medical device recalls database, and the Establishment Registration and Device Listing database. Philips counts include its registered medical-device subsidiaries — most importantly Philips Respironics (sleep and respiratory care), Volcano (intravascular ultrasound), and Spectranetics (laser angioplasty) — because these entities operate under the Philips FDA footprint even where the legacy applicant name is retained. Raw recall counts are reported as filed and must be read against installed base: Philips' recall total is heavily inflated by the multi-year Respironics PE-PUR foam field action and its aftermath, so the headline number is not a like-for-like quality comparison with a company that has not undergone a comparable mass recall. This same methodology is applied across our peer company profiles so the figures are directly comparable, and any reader who wants to reproduce a count should group records under the brand and named subsidiaries rather than relying on a single applicant string.
The 510(k) Clearance Portfolio: Radiology, Cardiovascular, and Anesthesia
The 510(k) premarket notification pathway is the primary method for Philips to clear diagnostic hardware, patient monitors, and clinical software for commercial use in the United States.
As of June 2026, Philips and its registered subsidiaries hold 1,322 active 510(k) clearances. Segmenting these clearances by FDA medical specialty reveals a highly diverse clinical footprint:
| Medical Specialty | Clearance Count | Percentage of 510(k) Portfolio | Core Technologies |
|---|---|---|---|
| Radiology | 654 | 49.47% | Magnetic Resonance Imaging (MRI), Computed Tomography (CT), ultrasound |
| Cardiovascular | 327 | 24.74% | Interventional X-ray (Azurion), cardiac ultrasound, Volcano catheter systems |
| Anesthesiology | 217 | 16.41% | CPAP/BiPAP systems, clinical ventilators, gas analyzers |
| Ear, Nose, Throat | 24 | 1.82% | Sleep apnea oral appliances, ENT diagnostic scopes |
| General & Plastic Surgery | 21 | 1.59% | Surgical lasers, light-based therapy devices |
| Other Specialties | 79 | 5.97% | Neurology, pathology, general hospital, pediatric care |
| Total Active Clearances | 1,322 | 100.00% |
Top 510(k) Product Codes and Device Families
The top five product codes within Philips' 510(k) portfolio represent their leadership in MRI, ultrasound, radiological software, and respiratory care:
- LNH (125 clearances): System, Nuclear Magnetic Resonance Imaging (21 CFR 892.1000, Class II). This code covers the Philips Elition, Ingenia, and MR Prodiva MRI scanner series.
- MHX (87 clearances): Monitor, Physiological, Patient (With Arrhythmia Detection or Alarms) (21 CFR 870.1025, Class II). This code represents Philips' flagship IntelliVue patient monitoring platforms (including the MX, MX800, and bedside monitors) used across ICUs, operating rooms, and step-down units.
- LLZ (81 clearances): System, Image Processing, Radiological (21 CFR 892.2050, Class II). This covers the Philips IntelliSpace imaging software suite and Picture Archiving and Communication Systems (PACS).
- BZD (79 clearances): Ventilator, Non-Continuous (Respirator) (21 CFR 868.5905, Class II). This code covers CPAP and BiPAP systems developed by Philips Respironics for treating obstructive sleep apnea (OSA).
- JAK (71 clearances): System, X-Ray, Tomography, Computed (21 CFR 892.1750, Class II). This covers the computed tomography (CT) scanner portfolio, including the Brilliance, IQon Spectral, and Spectral CT 7500 platforms.
Philips Top 510(k) Product Codes:
LNH (Magnetic Resonance): [========================] 125
MHX (Patient Monitoring): [=================] 87
LLZ (Radiological Software): [================] 81
BZD (Non-Continuous Vent): [===============] 79
JAK (Computed Tomography): [=============] 71
Annual Clearance Trends (2020–2026)
By analyzing decision dates in the FDA 510(k) database, we track Philips' clearance volume:
| Year | Clearance Volume | Key Product Clearances & Strategic Context |
|---|---|---|
| 2020 | 36 | High volume of clinical monitoring interfaces and diagnostic ultrasound probes. |
| 2021 | 31 | Clearance of Azurion interventional suites and initial software-based MRI updates. |
| 2022 | 19 | Lower clearance volume; focus on quality systems adjustments and compliance monitoring. |
| 2023 | 18 | Focus on Spectral CT upgrades and remote diagnostic telemetry software. |
| 2024 | 27 | Introduction of IntelliSpace portal upgrades and new ultrasound transducer models. |
| 2025 | 36 | Increased activity; clearance of portable clinical monitoring software and updated AED configurations. |
| 2026 (Part) | 19 | Mid-year run-rate; includes Elevate Plus AI-powered workflow automation software for ultrasound systems. |
This trend shows a dip in clearance volume during 2022–2023, reflecting a period of corporate focus on resolving the Respironics recall, followed by a strong recovery in 2025–2026 as imaging and monitoring software innovations were cleared.
Premarket Approval (PMA) Distribution: Cardiovascular Interventions
Premarket Approval (PMA) is the FDA's most rigorous device clearance pathway, required for Class III devices that support human life or present a high potential risk.
While competitors like Siemens focus their PMAs on laboratory diagnostics, Philips holds 350 PMA approvals and supplements that are heavily concentrated in cardiovascular interventions and defibrillation. This footprint was expanded through acquisitions, particularly Volcano Corporation in 2015 and The Spectranetics Corporation in 2017.
The top five product codes representing Philips' PMA portfolio are:
- LPC (124 filings): Device, Angioplasty, Laser, Coronary (Class III). This represents the excimer laser coronary angioplasty systems and disposable laser catheters developed by Spectranetics (such as the ELCA catheter series) used to treat complex arterial blockages.
- MFA (62 filings): Device, Removal, Pacemaker Electrode, Percutaneous (Class III). This code covers mechanical and laser lead extraction systems (such as the GlideLight laser sheath) used to remove cardiac pacemaker and defibrillator leads.
- NWX (33 filings): Catheter, Percutaneous Transluminal Coronary Angioplasty (PTCA), Cutting/Scoring (Class III). This represents cutting and scoring balloon catheters used in complex percutaneous coronary interventions (PCI).
- MKJ (28 filings): Automated External Defibrillators (Non-Wearable) (21 CFR 870.5310, Class III). This code covers Philips' HeartStart automated external defibrillator (AED) lines, which are subject to premarket approval to ensure high reliability.
- NSA (27 filings): Over-The-Counter Automated External Defibrillator (21 CFR 870.5310, Class III). Covers AED systems cleared for over-the-counter public access deployment, ensuring public safety.
This Class III portfolio highlights Philips' leadership in the cath lab, providing specialized tools for laser angioplasty, lead extraction, and coronary imaging. Managing these PMAs requires clinical trial evidence and strict post-market registries to track long-term clinical safety.
Strategic Clinical Value of the Volcano and Spectranetics PMA Portfolios
The incorporation of the Volcano and Spectranetics portfolios represented a deliberate transition for Royal Philips: shifting from a manufacturer of passive diagnostic imaging consoles to a provider of active interventional therapy platforms.
- Volcano Intravascular Ultrasound (IVUS) Systems: Volcano's PMAs (led by product code LPC and clinical equivalents) represent catheters and consoles that provide real-time ultrasound imaging from inside the coronary arteries. Unlike traditional angiography, which displays a 2D silhouette of blood flow, IVUS allows clinicians to see cross-sectional vessel wall pathology, measure plaque burden, and verify stent expansion. From a regulatory perspective, maintaining Volcano's catheter PMAs involves managing continuous design validation studies for catheter trackability, pushability, and transducer performance.
- Spectranetics Excimer Laser Coronary Angioplasty (ELCA): The Spectranetics laser catheter portfolio (represented by product code LPC) utilizes cool ultraviolet laser energy to photoablate calcified arterial plaque and thrombus. Because laser catheter insertion poses risks of coronary dissection or perforation, the FDA regulates these systems under strict Class III PMA controls. This requires Philips to track long-term safety data in clinical registries, and submit PMA supplements for any modifications to the catheter fibers, laser generator, or QMS parameters.
- Lead Extraction Systems: The percutaneous lead extraction sheaths (represented by product code MFA) allow clinicians to remove old or infected pacemaker wires. This is a high-risk procedure due to the proximity of the leads to the superior vena cava and heart chambers, requiring robust clinician training programs and detailed warning labels governed by the FDA.
By integrating these specialized Class III technologies with its Azurion angiography systems, Philips has built an image-guided therapy ecosystem. For hospital procurement, this integration means that evaluating Philips' cardiovascular business requires auditing active PMAs across multiple legacy legal entities.
FDA Recalls and Safety Signals: The Sleep & Respiratory Consent Decree
Managing safety alerts and field corrections is a critical compliance activity for healthcare risk managers. As of June 2026, FDA records associate 2,397 medical device recalls with Philips and its registered subsidiaries.
Annual Recall Trends (2020–2026)
Tracking the annual recall initiation dates for Philips highlights the safety management of its diverse product lines:
| Year | Recall Volume | Core Product Lines Affected | Strategic Context & Regulatory Rationale |
|---|---|---|---|
| 2020 | 78 | Defibrillator pads, MRI software | Software updates for MR software packages, battery connector wear in AEDs. |
| 2021 | 115 | Respironics CPAP/BiPAP, patient monitors | Spikes due to the massive PE-PUR foam sleep and respiratory recall initiation. |
| 2022 | 52 | IntelliVue monitors, SPECT detector systems | Defibrillator calibration, monitor display software corrections. |
| 2023 | 120 | Philips Respironics accessories, CT systems | Software corrections for imaging systems, ventilator filters, sleep therapy tube components. |
| 2024 | 180 | HeartStart AEDs, interventional X-ray | High recall volume; central station monitoring dropouts, AED self-test warnings. |
| 2025 | 345 | Azurion fluoroscopy, BiPAP ventilators | Significant recall surge; interventional cooling system hoses, BiPAP alarm failures. |
| 2026 (Part) | 72 | Remote diagnostics, imaging central software | Diagnostic interface connection dropouts, software image display anomalies. |
This trend shows a high volume of recalls in 2024–2025, representing an aggressive push to address software anomalies and hardware components (like the interventional cooling system hoses) in the field.
Recall Distribution by Product Code
An analysis of Philips' recalls by product code reveals that imaging capital equipment and cardiac defibrillators represent the highest recall counts:
| Rank | Product Code | Device Category | Number of Recalls | Primary Recall Root Causes |
|---|---|---|---|---|
| 1 | JAK | Computed Tomography (CT) | 396 | Software reconstruction anomalies, gantry software bugs, mechanical wear |
| 2 | LNH | Magnetic Resonance Imaging (MRI) | 343 | Superconducting magnet pressure limits, software bugs, ceiling speaker issues |
| 3 | OWB | Interventional Fluoroscopic X-Ray System | 276 | Cooling hose degradation, mechanical joint wear, display bugs |
| 4 | KPS | Computed Emission Tomography (PET/SPECT) | 151 | Detector software errors, motion table calibration faults |
| 5 | MKJ | Automated External Defibrillator (AED) | 110 | Internal battery connector wear, software self-test failure alerts |
The Philips Respironics Consent Decree (April 2024–Present)
The most significant regulatory event in Philips' history is the June 2021 recall of millions of Respironics CPAP, BiPAP, and mechanical ventilator devices due to the degradation of the polyester-based polyurethane (PE-PUR) sound abatement foam.
- The Consent Decree (April 2024): Philips Respironics entered into a formal Consent Decree with the U.S. Department of Justice (DOJ) and the FDA. Under this decree, Philips is prohibited from selling new CPAP, BiPAP, and selected other respiratory care devices in the U.S. market until it meets strict regulatory requirements, including completing independent quality audits and receiving formal FDA authorization.
- Progress in 2026: Philips reported that global remediation of actionable sleep therapy device registrations is 99% complete, while remediation efforts for clinical ventilators are ongoing.
- Patient Portal Closure (January 1, 2026): Philips officially closed its U.S. Patient Portal for affected CPAP and BiPAP registrations, shifting unresolved claims to direct support channels.
- Active U.S. Restrictions: While Philips is permitted to service existing devices and supply replacement parts, consumables, and accessories under the consent decree, it remains restricted from selling new sleep apnea devices in the United States, keeping the division's commercial operations limited.
Recent Safety Alerts (2025–2026)
Aside from the Respironics recall, Philips has managed other safety alerts in its imaging and clinical divisions:
- Class II Interventional X-Ray Cooling Hose Recall (May 2026): Philips issued a recall for its Allura and Azurion interventional fluoroscopy systems due to degradation in the cooling system hoses. The degradation could lead to fluid leaks, potentially impacting the system's X-ray tube cooling. Philips scheduled field service remediation to replace affected hoses starting in early 2027.
- Class I Ventilator Correction (August 2025): The FDA designated a correction for certain Philips Respironics V30, A30, and A40 ventilators as a Class I recall over the risk of interruptions and/or loss of therapy for patients who depend on the device for life-sustaining ventilation. Philips addressed the issue through updated instructions for use rather than a physical device modification, illustrating how high-severity recalls are sometimes managed through labeling and workflow controls rather than hardware replacement.
Global Supply Chain and Facility Analysis
The FDA's Establishment Registration database lists the facilities registered to manufacture and process medical devices for the U.S. market.
Philips holds 5,180 active establishment registration and device listings across its registered entities.
Our analysis of the geographic hubs in Philips' FDA listings reveals a highly globalized supply chain:
| Location | Active Listings | Primary Product Focus | Supply Chain Significance |
|---|---|---|---|
| Mississauga, Canada | 1,177 | Patient Monitors, Remote Diagnostic Systems | Largest single facility by listing count; represents remote patient monitoring and ultrasound distribution operations. |
| Boeblingen, Germany | 593 | Patient Monitoring Systems, Modules | Core European center of excellence for clinical patient monitoring systems (IntelliVue series). |
| Best, Netherlands | 445 | Interventional X-Ray, MRI Scanners | Philips' flagship global manufacturing plant for high-value diagnostic imaging systems. |
| Cambridge, MA | 470 | Corporate R&D, Digital Health, AI Development | North American headquarters and center for digital health software and clinical research. |
| Bengaluru, India | 295 | Software Engineering, Digital Health R&D | Key global R&D center focused on clinical software development and imaging informatics. |
This geographic breakdown reveals that while Philips is headquartered in Amsterdam, Netherlands, its manufacturing operations are highly distributed. The high volume of listings in Mississauga (1,177) and Boeblingen (593) highlights a strong focus on clinical monitoring and remote diagnostic systems, while its flagship imaging hardware manufacturing is centered in Best, Netherlands (445).
Risk Management Framework for Healthcare Procurement
When managing a fleet of Philips medical systems, hospital procurement, clinical engineering, and risk management teams should implement a structured assessment workflow to evaluate and mitigate regulatory risks. Because Philips operates legally and operationally distinct business units, the workflow must begin by separating sleep and respiratory devices from imaging, monitoring, and interventional capital equipment before any vendor decision is made.
+-----------------------------+
| Identify Business Unit |
| - Sleep/Respi vs Imaging |
| - Diagnostics vs Cath Lab |
+--------------+--------------+
|
v
+-----------------------------+
| Assess Consent Decree Status|
| - Confirm Respironics |
| compliance milestones |
+--------------+--------------+
|
v
+-----------------------------+
| Evaluate Facility Quality |
| - Check Best (NL) or |
| Boeblingen (DE) status |
+--------------+--------------+
|
v
+-----------------------------+
| Implement QA SLA Check |
| - Track software updates |
| - Audit cooling hose wear |
+-----------------------------+
1. Segment Risk by Business Unit
Risk managers must distinguish between Philips' business units. The regulatory restrictions and consent decree affecting Philips Respironics do not impact the Diagnosis & Treatment division. Ultrasound (EPIQ, Affiniti), interventional X-ray (Azurion), and MRI systems are manufactured in separate facilities (primarily in Best, Netherlands) under distinct QMS frameworks. Do not disqualify Philips' imaging systems based on Respironics' history. Build a simple two-track risk register — one for sleep and respiratory devices governed by the decree, one for imaging, monitoring, and interventional capital — and update them on independent cadences.
2. Manage CPAP and Ventilator Lifecycle
For facilities using legacy Philips Respironics CPAP, BiPAP, or clinical ventilators:
- Verify that all registered devices have completed the PE-PUR foam remediation process.
- Ensure that the facility has a clear transition plan for CPAP and BiPAP devices, given the current U.S. sales restrictions.
- Maintain contact with Philips for replacement parts and accessories, which are still permitted for distribution under the consent decree.
- Track the August 2025 Class I ventilator correction (V30, A30, A40) and confirm that updated instructions for use have been distributed to every clinical user.
3. Establish QA Inspection Protocols for Capital Equipment
For clinical engineering teams managing interventional fluoroscopy systems (Allura and Azurion):
- Audit cooling system hoses for signs of degradation during scheduled preventative maintenance.
- Coordinate with Philips service representatives to schedule the cooling hose upgrades planned for early 2027.
- Ensure that all centralized patient monitoring systems (IntelliVue) are placed on secure, segmented networks to prevent cybersecurity issues.
- Log the specific CU3101 cooling-unit batch references so affected systems can be identified quickly when the 2027 remediation wave begins.
How Philips Compares With GE HealthCare and Siemens Healthineers
Philips' regulatory footprint differs structurally from its two largest imaging-OEM peers because of the Respironics overhang and its cardiovascular acquisitions:
| Regulatory Metric | Philips | GE HealthCare | Siemens Healthineers |
|---|---|---|---|
| Active 510(k) clearances | 1,322 | 1,680 | 1,573 |
| PMA approvals / supplements | 350 | 95 | 540 |
| FDA-registered recalls | 2,397 | 1,490 | 2,042 |
| Establishment / device listings | 5,180 | 5,512 | 4,114 |
| Leading 510(k) product code | LNH — MRI (125) | IYN — ultrasound (179) | JAK — CT (155) |
| PMA portfolio focus | Cardiovascular (LPC, 124) | Breast / mammography (MUE, 37) | In-vitro diagnostics (LOM, 189) |
| Defining regulatory event | Respironics consent decree (Apr 2024) | Infant blender Class I (Jun 2026) | MRI venting Class I (Aug 2025) |
Two points matter for buyers. First, Philips' recall count (2,397) is the highest of the three, but that figure is dominated by sleep and respiratory devices under an active federal consent decree — it is not representative of the imaging and monitoring divisions that most hospitals actually procure from. Second, Philips holds the largest cardiovascular PMA book of the three (350, led by laser angioplasty and lead-extraction devices from the Volcano and Spectranetics acquisitions), making it the natural incumbent in image-guided therapy suites. For the cross-industry recall picture, see our FDA medical device recall manufacturer concentration analysis; for the broader spin-off context behind these independent companies, see our medtech divestitures and spinoffs guide.
Common Pitfalls When Auditing a Philips Footprint
- Conflating business units. The Respironics consent decree and its recall history do not affect Philips' Diagnosis & Treatment imaging systems (Azurion, EPIQ, IntelliSpace), which are manufactured in separate facilities under distinct quality systems. Disqualifying Philips imaging because of Respironics is an avoidable procurement error.
- Misreading the recall denominator. Because the PE-PUR foam recall touched roughly 15 million devices worldwide, Philips' recall frequency in 2021 and the remediation years that followed is structurally elevated. Segment recall analysis by business unit before benchmarking against peers.
- Forgetting consent-decare service continuity. Under the decree Philips may still service installed Respironics devices and supply replacement parts, consumables, and accessories in the U.S., but it cannot sell new CPAP/BiPAP machines. Hospitals relying on Philips sleep devices must plan replacements from other manufacturers while continuing to maintain the installed base.
- Overlooking acquisition-driven PMA sprawl. Philips' cardiovascular PMAs are spread across legacy Volcano and Spectranetics legal entities. A complete cath-lab procurement audit must trace active PMAs across those entities, not just "Philips."
What the Footprint Numbers Mean for Your Risk Model
A regulatory footprint is only useful if it changes a decision. For Philips, three quantitative signals translate directly into procurement and risk-management action:
- The consent decree defines the Respironics replacement clock. Because Philips cannot sell new CPAP/BiPAP machines in the U.S. until the decree's requirements are met, any facility relying on Philips Respironics sleep devices is on a forced multi-year replacement cycle. The footprint makes the timeline concrete: plan capex for replacement devices from alternative manufacturers while budgeting separately for ongoing service of the installed Philips base.
- The cardiovascular PMA book defines cath-lab lock-in. With LPC (laser angioplasty, 124 filings) and MFA (lead extraction, 62 filings) as the leading PMA codes, a hospital that standardizes its image-guided therapy suite on Azurion is buying into a tightly coupled Philips interventional ecosystem. That delivers integration benefits, but it also means future capital decisions (lasers, sheaths, software) are constrained by Philips' PMA supplement cadence.
- The recall denominator demands segmentation. Philips' ~2,397 recalls cannot be benchmarked against a peer that has not run a 15-million-device field action. Segment the data: the Respironics-dominated sleep/respiratory recalls tell you about consent-decree execution, while the imaging recalls (CT, MRI, interventional X-ray) tell you about capital-equipment service quality — and those are the numbers relevant to an imaging procurement decision.
The practical test is whether the footprint changes how you write the contract. For imaging and monitoring capital, a sound Philips agreement specifies Class I/II recall notification latency, cooling-hose and interventional-system remediation timing, cybersecurity patch cadence, and — separately, for any Respironics devices — the consent-decree service continuity terms.
What is the status of the Philips Respironics consent decree?
As of mid-2026, Philips remains under the requirements of the April 2024 Consent Decree. While the company is permitted to service existing devices and supply replacement parts, consumables, and accessories, it remains restricted from selling new sleep apnea or respiratory devices in the United States until it meets specific regulatory requirements.
Which clinical specialty dominates Philips' 510(k) clearances?
Radiology is the dominant specialty, representing 49.47% (654 clearances) of Philips' 1,322 active clearances. Cardiovascular devices represent the second largest category with 24.74% (327 clearances).
Why does product code LPC represent the highest PMA count for Philips?
Product code LPC stands for Device, Angioplasty, Laser, Coronary. It represents coronary laser angioplasty systems and catheters acquired through the acquisition of Spectranetics, which is a key part of Philips' interventional cardiology portfolio.
Where are Philips' primary FDA-registered manufacturing facilities?
Philips' primary registered facilities are located in Mississauga, Canada (1,177 listings for monitoring), Boeblingen, Germany (593 listings for clinical monitors), and Best, Netherlands (445 listings for interventional X-ray and MRI systems).
Why is Philips' recall count higher than GE HealthCare's or Siemens'?
Philips' ~2,397 recalls are inflated by the multi-year Respironics PE-PUR foam field action and the correction work that followed the June 2021 recall of roughly 15 million sleep and respiratory devices. Once that single program is separated out, Philips' imaging and monitoring recall profile is comparable to its peers, which is why buyers should segment recalls by business unit rather than compare raw totals.
Can a U.S. hospital still buy new Philips Respironics CPAP or BiPAP machines?
No. Under the April 2024 consent decree, Philips Respironics is restricted from selling new CPAP, BiPAP, and certain other respiratory care devices in the United States until it meets specific remediation and quality-system requirements and receives written FDA authorization. Philips may continue to service installed devices and to supply replacement parts, consumables, and accessories.
How did the Volcano and Spectranetics acquisitions change Philips' PMA footprint?
They moved Philips from a mostly imaging-and-monitoring company into an active interventional-therapy company. Volcano added intravascular ultrasound consoles and catheters, and Spectranetics added excimer laser coronary angioplasty systems and lead-extraction sheaths — collectively making product code LPC (laser coronary angioplasty) Philips' largest PMA code with 124 filings and giving Philips the largest cardiovascular PMA book among the three major imaging OEMs.
Should a hospital avoid Philips imaging systems because of the Respironics consent decree?
No. The consent decree and its recall history apply specifically to Philips Respironics sleep and respiratory care. The Diagnosis & Treatment imaging systems (Azurion, EPIQ, IntelliSpace) and patient monitors (IntelliVue) are manufactured in separate facilities under distinct quality systems and are not subject to the decree. Each business unit should be evaluated on its own regulatory record.
When can Philips Respironics resume selling new CPAP and BiPAP machines in the U.S.?
Only after Philips Respironics completes the recall remediation plan and brings the covered facilities into compliance with current good manufacturing practice, medical device reporting, and correction-and-removal requirements, and then receives written notice from the FDA. The consent decree does not set a fixed calendar date, which is precisely why hospitals should not assume a near-term resumption and should plan sleep-therapy device supply around alternative manufacturers in the meantime. Philips may continue to export new devices outside the U.S. and to service and supply accessories for the installed base during this period.
Bottom Line for Procurement and Regulatory Teams
Philips' FDA footprint describes a dual-profile company: a high-performing imaging, monitoring, and cardiovascular-interventional business, and a sleep-and-respiratory business operating under an active federal consent decree. The actionable conclusions follow that split: for imaging and cath-lab capital, evaluate Philips on its imaging recall and PMA record and write contracts that cover interventional-system cooling-hose remediation and patch cadence; for any Respironics devices, plan a multi-year replacement strategy around the decree while continuing to maintain and service the installed base. The headline recall number is large, but once it is segmented by business unit, Philips' imaging footprint is competitive with its peers — which is exactly the analysis a defensible procurement decision requires.
Sources
- FDA Medical Device Databases: U.S. Food and Drug Administration. Access data source for 510(k), Premarket Approval, and Recall registries. FDA Medical Device Databases
- Philips Respironics Consent Decree Information: Official statements and regulatory updates regarding the DOJ consent decree. Philips News Archive
- FDA Establishment Registration Database: Registry of active medical device manufacturers and listed devices. FDA Establishment Registration
- U.S. DOJ Consent Decree Announcement: Public filing regarding the Philips Respironics consent decree restrictions. U.S. Department of Justice
- FDA Recall Classifications and Safety Notifications: Public database of safety alerts and field corrective actions. FDA Recalls Database
Disclaimer: This analysis is based on the June 10, 2026 extracts of the FDA 510(k), PMA, Recalls, and Establishment Registration databases, alongside public announcements from the 2025–2026 period. It is intended for educational and market research purposes only and does not constitute legal, regulatory, or clinical advice for any specific product, institution, or clinical application.