Siemens Healthineers FDA Footprint: 510(k), PMA & Recalls Guide
A comprehensive, data-driven regulatory dossier analyzing Siemens Healthineers' FDA 510(k) clearances, PMA approvals, recalls, and global manufacturing footprint.
Executive Summary
What does the FDA database reveal about Siemens Healthineers' medical device clearance history, recalls, and manufacturing footprint?
Siemens Healthineers holds 1,573 active 510(k) clearances and 540 PMA approvals or supplements, reflecting its dominant position in global medical imaging and in vitro diagnostics. Our database analysis reveals that Siemens' 510(k) clearances are heavily concentrated in the Radiology specialty (985 clearances, or 62.62%), led by computed tomography (CT) systems (product code JAK, 155 clearances) and magnetic resonance imaging (MRI) systems (product code LNH, 154 clearances). In the high-risk premarket approval (PMA) sector, Siemens' portfolio is dominated by legacy clinical chemistry and immunodiagnostic assays, particularly Hepatitis B test kits (product code LOM, 189 records).
However, this massive footprint is accompanied by 2,042 FDA-registered recalls, with linear accelerators (product code IYE, 218 recalls) and fluoroscopic imaging systems (product code OWB, 217 recalls) representing the highest recall frequencies. Geographically, Siemens Healthineers operates a globalized manufacturing network with major hubs in Tarrytown, NY (734 listings), Newark, DE (630 listings), and Forchheim, Germany (422 listings).
Siemens Healthineers FDA Footprint at a Glance
- 510(k) clearances: 1,573 (Radiology 985 / Clinical Chemistry 162)
- PMA approvals and supplements: 540 (led by Hepatitis B assay LOM — 189)
- FDA-registered recalls: 2,042 (led by linac IYE — 218, fluoroscopy OWB — 217)
- Establishment / device listings: 4,114 (Tarrytown, Newark, Forchheim lead)
- Unique business line: radiation oncology via the 2021 Varian acquisition (~$16.4 billion)
- Defining 2025 event: August 2025 Class I recall of 3T Magnetom and Biograph MRI systems over helium venting
Introduction to Siemens Healthineers' Regulatory Profile
Siemens Healthineers (a spin-off of the German conglomerate Siemens AG) is one of the world's largest medical technology companies. Following its independent public listing in 2018 and its landmark $16.4 billion acquisition of Varian Medical Systems in 2021, the company has structured its operations into four core segments: Imaging (CT, MRI, ultrasound, molecular imaging, and X-ray), Diagnostics (clinical chemistry, immunodiagnostics, hematology, and molecular diagnostics), Varian (radiation oncology), and Advanced Therapies (interventional radiology and cardiology). That breadth matters for a regulatory footprint analysis: unlike a pure imaging OEM, Siemens Healthineers carries a large high-risk in-vitro diagnostics PMA book and a radiation-oncology linac fleet, each with very different compliance and service profiles.
For regulatory affairs (RA) professionals, hospital procurement committees, and medtech competitors, evaluating a company of this scale requires looking beyond marketing brochures and analyzing official regulatory databases. Every diagnostic scanner, laboratory assay, software package, and therapeutic system sold in the United States must clear strict regulatory hurdles managed by the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH).
This dossier provides a comprehensive, quantitative analysis of Siemens Healthineers' FDA footprint. By mining and cross-referencing extracts 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 patterns, and geographic hubs that define Siemens' regulatory track record.
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. Siemens Healthineers counts are based on the Siemens-branded applicant and registrant entities (Siemens Medical Solutions, Siemens Healthcare Diagnostics, Siemens Healthineers, and related Siemens entities). We deliberately report the Siemens-brand footprint rather than consolidating every legacy acquired company (such as the pre-Siemens Dade Behring, Diagnostic Products Corporation, or Bayer Diagnostics submission names), so that the headline figures reflect the operating Siemens Healthineers entity as it registers devices today; readers should note that the historical IVD portfolio described in the PMA section sits behind some of those legacy names. Raw recall counts are reported as filed and must be read against installed base: a company with Siemens' scale in imaging and radiation-oncology capital equipment will generate more field corrections than a niche manufacturer, so a high recall count is not by itself a quality verdict. The same methodology is applied across our peer company profiles for direct comparability.
The 510(k) Clearance Portfolio: Radiology Dominance
A premarket notification under Section 510(k) of the Food, Drug, and Cosmetic Act requires a manufacturer to demonstrate that a new medical device is "substantially equivalent" to a legally marketed predicate device. For Siemens Healthineers, the 510(k) pathway has been the primary vehicle for introducing commercial imaging systems and laboratory hardware to the U.S. market.
As of June 2026, Siemens Healthineers holds 1,573 active 510(k) clearances. Our analysis of these clearances by FDA advisory committee and medical specialty reveals a highly concentrated portfolio:
| Medical Specialty | Clearance Count | Percentage of 510(k) Portfolio | Key Technologies Covered |
|---|---|---|---|
| Radiology | 985 | 62.62% | Computed Tomography (CT), MRI, X-Ray, PET/SPECT, PACS software |
| Clinical Chemistry | 162 | 10.30% | Automated analyzers, chemistry panels, drug screening assays |
| Cardiovascular | 146 | 9.28% | Angiography systems, cardiac ultrasound, electrophysiology software |
| Anesthesiology | 59 | 3.75% | Blood gas analyzers, co-oximeters, patient monitors |
| Immunology | 55 | 3.50% | Automated immunoassay kits, infectious disease serology panels |
| Other Specialties | 166 | 10.55% | Hematology, pathology, neurology, general surgery, radiation oncology |
| Total Active Clearances | 1,573 | 100.00% |
Top 510(k) Product Codes and Device Classes
Analyzing the specific product codes assigned to Siemens' 510(k) clearances provides a clearer picture of their core product lines. The top five product codes representing Siemens' 510(k) clearances are:
- JAK (155 clearances): System, X-Ray, Tomography, Computed (21 CFR 892.1750, Class II). This code covers the Somatom computed tomography (CT) scanner series, ranging from legacy emotion systems to the latest dual-source Somatom Drive and photon-counting Naeotom Alpha platforms.
- LNH (154 clearances): System, Nuclear Magnetic Resonance Imaging (21 CFR 892.1000, Class II). This code encompasses the Magnetom magnetic resonance imaging (MRI) scanner series, including the 1.5T Aera and Altea, 3T Skyra and Vida, and ultra-high-field 7T Terra systems.
- LLZ (133 clearances): System, Image Processing, Radiological (21 CFR 892.2050, Class II). This covers the syngo suite of imaging software, Picture Archiving and Communication Systems (PACS), and advanced post-processing workstations that support clinical decision-making.
- IYN (102 clearances): System, Imaging, Pulsed Doppler, Ultrasonic (21 CFR 892.1550, Class II). This code represents Siemens' diagnostic ultrasound systems, including the Acuson Sequoia, Redwood, and Juniper series used in cardiovascular and general imaging.
- KPS (61 clearances): System, Tomography, Computed, Emission (21 CFR 892.1200, Class II). This code covers molecular imaging systems, including the Biograph PET/CT and SPECT/CT series.
Siemens Healthineers Top 510(k) Product Codes:
JAK (Computed Tomography): [==============================] 155
LNH (Magnetic Resonance): [=============================] 154
LLZ (Radiological Software): [==========================] 133
IYN (Pulsed Doppler Ultrasound): [====================] 102
KPS (Emission Tomography): [============] 61
Annual Clearance Trends (2020–2026)
By analyzing the decision dates in the FDA's 510(k) database, we can track the volume of new clearances issued to Siemens Healthineers. This trend provides a proxy for the company's research and development (R&D) cycles and regulatory submission activity.
| Year | Clearance Volume | Key Product Clearances & Strategic Context |
|---|---|---|
| 2020 | 43 | Focus on rapid clinical chemistry assays and basic portable imaging in response to the COVID-19 pandemic. |
| 2021 | 35 | Integration of Varian oncology planning software systems and advanced imaging interfaces. |
| 2022 | 41 | Rollout of Magnetom Free.Max (helium-free MRI) and next-gen Somatom CT software updates. |
| 2023 | 47 | Peak clearance year; heavy rollout of syngo AI post-processing software and Naeotom Alpha CT iterations. |
| 2024 | 35 | Launch of Luminos Q.namix radiography/fluoroscopy platforms and automated clinical software modules. |
| 2025 | 32 | Clearance of PET/MRI systems and Varian TrueBeam updates for non-oncology indications. |
| 2026 (Part) | 14 | Mid-year run-rate; includes Artis interventional imaging systems equipped with deep-learning-based Optiq AI. |
This trend shows a consistent baseline of 35 to 47 clearances per year, indicating continuous product lifecycle management. The peak in 2023 reflects a major regulatory push to transition imaging workstations and software tools to cloud-connected, AI-supported platforms.
Regulatory Pathway Shifts: Traditional vs. Special and Abbreviated
To maintain its competitive edge, Siemens Healthineers utilizes different 510(k) submission types:
- Traditional 510(k): Used for new devices where equivalence must be proved through comprehensive laboratory, animal, or clinical data.
- Special 510(k): Used for modifications to a manufacturer's own cleared device where the changes do not affect the intended use or alter the fundamental scientific technology. Special 510(k)s have a shortened 30-day review timeline compared to the 90-day traditional target.
- Abbreviated 510(k): Used when the submission relies on FDA-recognized consensus standards or guidance documents.
In recent years, Siemens has increasingly relied on the Special 510(k) pathway for software iterations and minor hardware updates across its Magnetom and Somatom lines, significantly reducing its time-to-market. Additionally, the company has been a pioneer in using the FDA's Predetermined Change Control Plan (PCCP) for AI-enabled software, allowing the algorithm to update within predefined parameters without requiring a new 510(k) submission.
Premarket Approval (PMA) Footprint: High-Risk Diagnostics
Premarket Approval (PMA) is the FDA's most stringent regulatory pathway, required for Class III devices that support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential, unreasonable risk of illness or injury.
While Siemens Healthineers is widely recognized for its imaging hardware, our analysis shows that it holds a substantial PMA portfolio of 540 approvals and supplements. Unlike companies like Medtronic or Boston Scientific, whose PMAs are concentrated in implantable therapeutic hardware (such as pacemakers or stents), Siemens' PMA footprint is heavily weighted toward high-risk in vitro diagnostics (IVDs).
This diagnostic PMA concentration is a direct result of Siemens' historical acquisitions in the laboratory space, including Dade Behring, Diagnostic Products Corporation (DPC), and Bayer Diagnostics.
The top five product codes within Siemens' PMA portfolio include:
- LOM (189 filings): Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) (21 CFR 866.3172, Class III). This code represents diagnostic test kits and reagents run on automated platforms (such as the Advia Centaur and Atellica systems) to detect Hepatitis B virus infection.
- MTG (71 filings): Test, Prostate Specific Antigen, Free (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions (21 CFR 866.6010, Class III). Free PSA assays used to help differentiate between prostate cancer and benign prostatic hyperplasia (BPH) in men with elevated total PSA.
- MTF (63 filings): Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer (21 CFR 866.6010, Class III). Assays used to measure total PSA in human serum to aid in the detection of prostate cancer.
- LOK (46 filings): Kit, Test, Alpha-Fetoprotein For Neural Tube Defects (21 CFR 866.6010, Class III). Diagnostic kits used to measure AFP levels in pregnant women to screen for fetal neural tube defects.
- LTJ (35 filings): Prostate-Specific Antigen (PSA) For Management Of Prostate Cancers (21 CFR 866.6010, Class III). Assays cleared specifically for monitoring patients with a history of prostate cancer to detect disease recurrence.
These high-risk diagnostic assays require clinical trial data demonstrating high clinical sensitivity and specificity. The regulatory burden for maintaining these PMAs is substantial, as any change to the reagent formulation, antibody clones, manufacturing site, or instrument software requires a PMA supplement (e.g., a 180-day Track Supplement or Real-Time Supplement).
FDA Recalls and Safety Signals: Analyzing the Patterns
A medical device recall is an action taken to address a problem with a medical device that violates FDA law. Recalls are categorized into three classes (Class I, II, and III) based on severity.
As of June 2026, FDA records associate 2,042 medical device recalls with Siemens Healthineers and its subsidiaries. While this count is high, it is critical for hospital administrators and risk managers to understand the "denominator effect": large market share and a massive installed base of highly complex systems naturally lead to more reportable events and corrections than smaller, niche players.
Annual Recall Trends (2020–2026)
By tracking when recalls were initiated, we can observe the temporal patterns of Siemens' safety actions:
| Year | Recall Volume | Primary Product Lines Involved | Common Safety Context & Root Causes |
|---|---|---|---|
| 2020 | 92 | Clinical Chemistry Reagents, MRI Systems | Calibration drift in assays, software errors in patient tables during COVID operations. |
| 2021 | 89 | Varian Linear Accelerators, SPECT/CT Systems | Software anomalies in treatment positioning, detector calibration defects. |
| 2022 | 92 | Atellica Assay Reagents, Somatom CT software | Reagent degradation under shipping stress, CT reconstruction software bugs. |
| 2023 | 51 | syngo Imaging Workstations, X-Ray Generators | Software package defects leading to diagnostic delay, hardware safety shut-off failures. |
| 2024 | 61 | Luminos X-Ray Systems, Acuson Ultrasound Probes | Mechanical linkage wear, cable insulation wear, software interface anomalies. |
| 2025 | 52 | Magnetom MRI systems, Varian TrueBeam Software | Ice blockages in MRI quench vents, Varian software calibration errors. |
| 2026 (Part) | 8 | Interventional Angiography, Clinical software | Fluoroscopy software bugs, un-cleared CT brain measurement applications. |
This timeline indicates that Siemens initiates an average of 50 to 95 recalls annually. The drop in recall counts in 2023–2025 suggests an improvement in the stability of software-heavy releases, though high-risk events still occur occasionally.
Recall Distribution by Product Code
To evaluate where the actual risks lie, we mapped the recall records to specific product codes:
| Rank | Product Code | Device Name / Category | Number of Recalls | Primary Recall Root Causes |
|---|---|---|---|---|
| 1 | IYE | Medical Linear Accelerator (Varian) | 218 | Software anomalies in treatment planning, mechanical calibration issues |
| 2 | OWB | Interventional Fluoroscopic X-Ray System | 217 | Component failure, software interface bugs, cooling system degradation |
| 3 | JAK | Computed Tomography X-Ray System (CT) | 163 | Software reconstruction bugs, detector artifacts, table positioning errors |
| 4 | KPS | Computed Emission Tomography (PET/SPECT) | 136 | Detector cooling failures, software correction tables, calibration drift |
| 5 | IZI | X-Ray Angiographic System | 99 | C-arm collision sensor faults, image freezing during fluoroscopy |
Key Safety Case Studies (2025–2026)
Two recent regulatory events highlight the active safety management required for Siemens' complex technology portfolio:
- Class I MRI Venting Recall (Late 2025): The FDA designated a correction action for several 3T Magnetom and Biograph MRI scanners as a Class I recall. The recall was triggered by a potential for ice blockage in the magnet venting system. If an emergency magnet quench occurred, the ice blockage could prevent helium gas from escaping safely, leading to pressure buildup that could rupture the helium containment system and potentially leak gas into the scanning room. Customers were instructed to avoid rebooting affected systems and wait for an engineer to install modified venting kits.
- Un-cleared Software Recall (December 2025): A Class II recall was issued for specific NAEOTOM Alpha CT software applications (such as syngo.CT Brain Quantification, Vessel Hyperdensities, and ASPECTS) because they were marketed and updated without receiving the required 510(k) clearance. Siemens advised users to disable the applications until formal clearances were finalized, illustrating the fine regulatory line between software-as-a-medical-device (SaMD) updates and new clearances.
Global Supply Chain and Facility Analysis
Analyzing the FDA's Establishment Registration and Device Listing database provides a look at Siemens Healthineers' manufacturing infrastructure. Foreign and domestic facilities that manufacture, prepare, propagate, compound, or process medical devices for the U.S. market must register annually and list the devices processed at their sites.
Siemens Healthineers holds 4,114 active establishment registration and device listings associated with its primary entities.
The top five manufacturing and distribution hubs in Siemens' FDA listings are:
| Location | Number of Active Listings | Primary Product Focus | Regulatory Importance |
|---|---|---|---|
| Tarrytown, NY | 734 | Clinical Chemistry and Immunoassay Reagents | Primary U.S. diagnostics manufacturing plant; handles massive PMA reagent portfolio. |
| Newark, DE | 630 | Diagnostic Chemistry Instruments and Consumables | Core manufacturing site for Atellica and Dimension instrumentation lines. |
| Forchheim, Germany | 422 | Computed Tomography (CT) and Angiography | Siemens' global center of excellence for CT hardware engineering (Somatom series). |
| Erlangen, Germany | 275 | Magnetic Resonance Imaging (MRI) | Corporate headquarters and primary manufacturing site for Magnetom MRI systems. |
| Pohang-si, South Korea | 250 | Ultrasound Transducers and Systems | Principal manufacturing site for ultrasound transducer components and arrays. |
This geographic distribution shows that while Siemens Healthineers is a German-headquartered company, its diagnostic reagent and clinical chemistry manufacturing is heavily centered in the United States (Tarrytown and Newark). In contrast, its flagship imaging systems (CT and MRI) are manufactured in Germany (Forchheim and Erlangen) and imported into the U.S., requiring robust import compliance operations at U.S. entry ports.
Decision-Making Framework for Healthcare Buyers and Risk Managers
For hospital procurement teams, clinical engineers, and risk managers, evaluating Siemens Healthineers requires a balanced view of their massive regulatory footprint. Rather than using raw recall counts as a simple safety ranking, operators should utilize a structured risk-mitigation framework that separates imaging, laboratory diagnostics, and radiation oncology, because each product family carries a different failure profile and consequence level.
+-----------------------------+
| Identify Product Code |
| (e.g., JAK, LNH, IYE) |
+--------------+--------------+
|
v
+-----------------------------+
| Assess Specific Recalls |
| - Software patch vs Recall |
| - Is physical return req? |
+--------------+--------------+
|
v
+-----------------------------+
| Evaluate Facility Quality |
| - Check Tarrytown / Newark |
| FDA inspection status |
+--------------+--------------+
|
v
+-----------------------------+
| Establish Vendor SLA Gate |
| - Include software patches |
| in clinical uptime SLAs |
+-----------------------------+
1. Segment by Business Unit and Facility
Do not treat a Siemens Healthineers molecular imaging scanner the same as a Siemens clinical chemistry analyzer. They are manufactured in different facilities under separate quality management systems (QMS). When assessing quality or compliance history, evaluate the specific manufacturing facility (e.g., Forchheim for CT, Erlangen for MRI, Tarrytown for Reagents). Capture the registered FEI number for each facility so that inspection histories and import holds can be tied to the exact site responsible for the product line you are buying.
2. Differentiate "Software Corrections" from "Physical Removals"
The vast majority of Siemens' recalls in the imaging and radiation oncology space are Class II software corrections. These are typically resolved via software patches or firmware updates rather than the physical removal of capital equipment. Buyers should ensure that their service contracts guarantee prompt installation of all safety-related software patches and that these patches are integrated into standard clinical engineering workflows.
3. Establish Quality System SLAs in Procurement
When purchasing high-value capital equipment (such as a Naeotom Alpha CT or TrueBeam Linear Accelerator), include specific service level agreements (SLAs) regarding regulatory corrections:
- Response Time: Require the vendor to notify the facility of any FDA-registered safety correction or recall within 48 hours of public listing.
- Remediation Timelines: Mandate that software patches for Class I or critical Class II recalls be deployed and verified on-site within 14 business days.
- Up-time Guarantees: Ensure that downtime associated with executing recalls is excluded from the system's guaranteed clinical uptime percentage.
How Siemens Healthineers Compares With GE HealthCare and Philips
Siemens Healthineers sits between its two largest imaging-OEM peers, but with two distinguishing features: the largest PMA book (driven by in-vitro diagnostics) and the addition of radiation oncology through Varian:
| Regulatory Metric | Siemens Healthineers | GE HealthCare | Philips |
|---|---|---|---|
| Active 510(k) clearances | 1,573 | 1,680 | 1,322 |
| PMA approvals / supplements | 540 | 95 | 350 |
| FDA-registered recalls | 2,042 | 1,490 | 2,397 |
| Establishment / device listings | 4,114 | 5,512 | 5,180 |
| Leading 510(k) product code | JAK — CT (155) | IYN — ultrasound (179) | LNH — MRI (125) |
| PMA portfolio focus | In-vitro diagnostics (LOM, 189) | Breast / mammography (MUE, 37) | Cardiovascular (LPC, 124) |
| Unique business line | Radiation oncology (Varian linacs) | Pharmaceutical diagnostics | Sleep & respiratory (under decree) |
The most important takeaway for buyers is the IVD concentration. Siemens Healthineers' 540 PMAs dwarf GE HealthCare's 95 and exceed Philips' 350, and they are concentrated in high-risk laboratory assays (hepatitis B, PSA, alpha-fetoprotein) run on Atellica, Advia Centaur, and Dimension platforms. That means a hospital's laboratory supply-chain and reagent-lot continuity risk looks very different from its imaging capital-equipment risk, even though both sit inside Siemens Healthineers. For the cross-industry recall picture, see our FDA medical device recall manufacturer concentration analysis, and for the corporate context behind Siemens Healthineers' independence and Varian acquisition, see our medtech divestitures and spinoffs guide.
Common Pitfalls When Auditing a Siemens Healthineers Footprint
- Mixing capital imaging with laboratory IVD. A CT scanner (Forchheim) and a clinical-chemistry analyzer (Tarrytown) are made in different countries under separate quality systems with unrelated failure modes. Audit each product family and facility on its own record.
- Underestimating radiation-oncology risk. Varian linear accelerators (product code IYE) are Siemens' single most-recalled code (218 recalls), because treatment-delivery errors carry the highest clinical consequence. Oncology departments should weight linac recalls more heavily than imaging software corrections.
- Reading recall totals at face value. Siemens' recall count is elevated by the scale of its installed base and by software-heavy updates; the operationally meaningful signal is Class I action response (such as the August 2025 MRI magnet-venting recall) and patch deployment cadence, not the gross number.
- Ignoring the dual U.S./Germany manufacturing split. Siemens' diagnostics reagents are concentrated in the U.S. (Tarrytown, Newark) while its flagship imaging systems are imported from Germany (Forchheim, Erlangen). Import disruptions and FDA inspection status at these sites affect different product lines and should be tracked separately.
What the Footprint Numbers Mean for Your Risk Model
A regulatory footprint is only useful if it changes a decision. For Siemens Healthineers, three quantitative signals translate directly into procurement and risk-management action:
- The IVD PMA book defines reagent-lot continuity risk. With 540 PMAs concentrated in hepatitis, PSA, and AFP assays on Atellica, Advia Centaur, and Dimension platforms, a laboratory running Siemens diagnostics inherits a large supplement-burden surface. Any reagent reformulation, antibody-clone change, or manufacturing-site move triggers a PMA supplement, which is why lab supply-chain managers must track Siemens reagent-lot change notices as closely as imaging teams track software patches.
- Radiation-oncology recalls carry asymmetric consequence. Linear accelerators (IYE) are Siemens' most-recalled code (218), but a treatment-delivery error is clinically catastrophic in a way an imaging software glitch is not. Oncology departments should weight linac recalls by severity, mandate treatment-planning software correction response times in the service contract, and maintain independent dosimetry verification rather than treat the recall count as a generic quality metric.
- The imaging software recall pattern signals a patch-management obligation. Siemens' heavy use of the Special 510(k) and PCCP pathways for software iterations means a continuously updating installed base. A risk committee should treat the 2024–2025 software-correction volume as a trigger to formalize patch-deployment SLAs, especially for AI post-processing tools that update in the background.
The practical test is whether the footprint changes how you write the contract. A sound Siemens Healthineers capital agreement separates imaging from IVD, specifies Class I recall notification latency (including linac and MRI magnet-venting actions), sets software-patch deployment windows, and clarifies which facility — Tarrytown, Newark, Forchheim, or Erlangen — is responsible for the specific product line being purchased.
What is the most common medical specialty for Siemens Healthineers' FDA clearances?
Radiology is by far the dominant medical specialty, accounting for 62.62% (985 clearances) of Siemens' 1,573 active 510(k) clearances. This includes computed tomography (CT), magnetic resonance imaging (MRI), ultrasound, and radiological imaging software.
What does product code JAK stand for, and why is it significant for Siemens?
Product code JAK stands for System, X-Ray, Tomography, Computed (21 CFR 892.1750, Class II). It is Siemens' most cleared product code with 155 active clearances, representing the company's flagship Somatom CT scanner series.
Are Siemens Healthineers' recalls dominated by high-risk Class I issues?
No. The vast majority of Siemens' 2,042 recalls are Class II events, which represent temporary or medically reversible risks. Many of these are resolved via remote software updates or technical service bulletins rather than system removals. However, the company has managed critical Class I events, such as the 2025 MRI magnet venting blockage recall.
Where are Siemens' main FDA-registered manufacturing facilities?
Siemens' primary FDA-registered manufacturing sites are in Tarrytown, NY (734 listings for diagnostics and reagents), Newark, DE (630 listings for chemistry instruments), and Forchheim, Germany (422 listings for CT and angiography systems).
Why does Siemens Healthineers hold so many more PMAs than GE HealthCare?
Siemens Healthineers' 540 PMAs are concentrated in high-risk in-vitro diagnostic assays — hepatitis B testing (LOM, 189 filings), PSA assays (MTG, MTF, LTJ), and alpha-fetoprotein screening (LOK) — run on its Atellica, Advia Centaur, and Dimension laboratory platforms. GE HealthCare's highest-risk devices sit in a much narrower breast-imaging line, so its PMA count is far smaller. A large PMA book reflects where a company competes in Class III, not overall capability.
What is the most serious recent Siemens Healthineers recall?
The August 2025 Class I recall of 3T Magnetom and Biograph MRI/PET-MR scanners over potential ice blockages in the magnet venting system. If an emergency magnet quench occurred with a blocked vent, helium gas could be trapped, potentially rupturing the helium containment system and releasing helium into the scanning room. Siemens advised customers not to reboot affected systems and to arrange an engineer inspection.
Does the Varian acquisition show up in Siemens Healthineers' recall profile?
Yes. Linear accelerators (product code IYE) are Siemens Healthineers' most-recalled product code (218 recalls), reflecting both the complexity of radiation-oncology treatment delivery and the large installed TrueBeam and linac base inherited through the 2021 Varian acquisition. Treatment-positioning software and mechanical calibration dominate the root causes, so oncology service contracts should explicitly cover safety-correction response times.
Why are Siemens Healthineers' top PMA codes all laboratory tests?
Because Siemens Healthineers is one of the largest in-vitro diagnostics companies in the world, and its high-risk (Class III) PMA portfolio is concentrated in IVD assays that require premarket approval — hepatitis B (LOM), PSA (MTG, MTF, LTJ), and alpha-fetoprotein (LOK) run on its Atellica, Advia Centaur, and Dimension platforms. Imaging systems are mostly Class II and cleared through 510(k), so they do not appear in the PMA ranking.
How does Siemens Healthineers keep updating imaging software so frequently?
Siemens Healthineers relies heavily on the Special 510(k) pathway for software iterations and minor hardware changes to its Magnetom MRI and Somatom CT lines — a route with a shortened review timeline — and on the FDA's Predetermined Change Control Plan for AI-enabled features, which lets a cleared algorithm update within pre-defined bounds without a new 510(k). That is efficient for time-to-market, but it also means a continuously updating installed base that hospital IT and clinical engineering teams must actively patch.
Bottom Line for Procurement and Regulatory Teams
Siemens Healthineers' FDA footprint describes the broadest OEM profile of the three major imaging peers: leadership in imaging hardware, the largest IVD PMA book, and a distinctive radiation-oncology franchise through Varian. The actionable conclusions are correspondingly segmented: laboratory teams must manage reagent-lot continuity against a large PMA supplement surface; oncology teams must weight linac recalls by consequence and mandate treatment-planning correction response times; and imaging teams must formalize software-patch SLAs around Siemens' heavy use of the Special 510(k) and PCCP pathways. Because diagnostics, imaging, and oncology sit in different facilities on different quality systems, every Siemens Healthineers contract should be scoped to the specific product family and the specific registered facility — that is where the regulatory database becomes a usable vendor-risk instrument.
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
- Siemens Healthineers Support & Documentation Portal: Customer safety notices and technical documentation database. Siemens Healthineers Support
- FDA Establishment Registration and Device Listing Database: Registry of medical device establishments and listed devices. FDA Establishment Registration
- Varian Medical Systems Product Safety Alerts: Safety notices and field corrective actions for linear accelerators and oncology software. Varian Product Safety
- FDA Class I Recall Registry: Listing of the most serious medical device recalls and corrections. 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.