FDA Anesthesia Machine Recalls: GE, Dräger & Getinge MAUDE Teardown
A manufacturer-spanning teardown of FDA anesthesia system recalls and MAUDE adverse events, analyzing GE Carestation, Dräger Atlan, and Getinge Flow.
Within the operating room (OR) environment, the anesthesia gas machine serves as the central life-support system. It integrates three clinical functions: precise delivery of inhalational anesthetic agents, continuous mechanical ventilation, and patient physiological monitoring. Because these devices are used on patients whose breathing is pharmacologically suppressed, any mechanical failure or software error in an anesthesia workstation can result in immediate hypoxia, brain injury, or death.
For clinical engineers, healthcare technology management (HTM) biomeds, anesthesiologists, and regulatory affairs directors, maintaining clinical continuity requires a deep understanding of post-market failure modes. This article provides a comprehensive, manufacturer-spanning teardown of FDA recalls and adverse-event reports from the Manufacturer and User Facility Device Experience (MAUDE) database for anesthesia machines and vaporizers, covering key workstations from GE HealthCare (Datex-Ohmeda), Dräger, Getinge (Maquet), and Mindray.
Executive Summary: Anesthesia System Recall and Safety Profile
- First-Screen Answer / Scenario Question Summary: FDA anesthesia machine and vaporizer recalls are led by GE, Dräger, and Getinge, clustering around four primary failure modes: (1) mechanical ventilation discontinuity (e.g., GE Carestation loose cables and Dräger Atlan ventilator-motor failures); (2) agent delivery inaccuracies (e.g., Mindray V90 output deviations and GE Aisys anesthetic boluses); (3) breathing-circuit leakage or misconnections (e.g., Getinge Flow suction switches and Datex-Ohmeda circuit misconnections); and (4) chemical or cybersecurity issues (e.g., Getinge sevoflurane degradation and Denial-of-Service vulnerabilities).
- Recall Volume & Concentration: The historical openFDA recall database contains 189 recalls for anesthesia delivery systems and vaporizers. The category is heavily dominated by product code BSZ (Gas-Machine, Anesthesia) with 172 recalls. GE HealthCare leads the historical recall footprint with 53 recalls, followed by Dräger (30), Getinge (14), and Mindray (9).
- MAUDE Volume & Malfunction Profile: In 2024, MAUDE captured 6,341 device-row reports associated with anesthesia delivery. Unlike implantable Class III devices (which are dominated by patient injuries), anesthesia workstations exhibit a malfunction-dominated profile, with 6,302 malfunctions (99.4%), 34 patient injuries, and 5 deaths reported.
- Product Code Dominance: Anesthesia gas machines (BSZ) drive the vast majority of MAUDE volume with 6,067 reports (95.7%), followed by electronic and non-heated vaporizers (CAD) with 256 reports and breathing gas mixers (BZR) with 18 reports.
- Strategic Takeaway: Because anesthesia systems are complex electro-mechanical devices, the vast majority of post-market safety issues are captured as malfunctions before they cause patient harm. This highlights the critical role of pre-use checklists, clinical alarms, and biomeds in mitigating risk before it reaches the patient.
Anesthesia System Product Codes and Regulatory Classification
The FDA categorizes anesthesia workstations as multi-component systems, splitting the main gas delivery machine from the vaporizers, gas mixers, software, and breathing circuits. Almost all components are classified as Class II medical devices under 21 CFR § 868. However, specialized software modules or high-risk accessories may be classified as Class III.
Below is the classification matrix for the primary anesthesia product codes analyzed in this teardown:
| Product Code | Device Description | Regulation Number | Device Class | Common Examples |
|---|---|---|---|---|
| BSZ | Gas-Machine, Anesthesia | 21 CFR 868.5160 | Class II | GE Carestation 600/700, Dräger Atlan A350, Getinge Flow-i, Mindray A9 |
| CAD | Vaporizer, Anesthesia, Non-Heated | 21 CFR 868.5880 | Class II | Dräger Vapor 2000 / 3000, Mindray V90 Electronic Vaporizer |
| BZR | Mixer, Breathing Gases, Anesthesia Inhalation | 21 CFR 868.5330 | Class II | In-line gas mixing manifolds and blenders |
| QSF | Software Option for Anesthesia Gas Machine | PMA (§515) | Class III | Automated lung protective ventilation or agent control software |
| NHO | Analyzer, Gas, Desflurane, Gaseous-Phase | 21 CFR 868.1500 | Class II | Anesthetic-agent concentration monitoring modules |
| NHP | Analyzer, Gas, Sevoflurane, Gaseous-Phase | 21 CFR 868.1500 | Class II | Anesthetic-agent concentration monitoring modules |
| NHQ | Analyzer, Gas, Isoflurane, Gaseous-Phase | 21 CFR 868.1500 | Class II | Anesthetic-agent concentration monitoring modules |
Analysis of FDA Recall Volumes and Manufacturer Concentration
To evaluate the historical distribution of official recalls, we analyzed the openFDA database. Filtering for product codes matching the anesthesia gas delivery set yielded 189 recalls.
A critical finding is that recalls are concentrated in four major global manufacturers. The table below outlines the distribution of recalls:
| Recalling Firm | Recall Count | Percentage of Dataset | Key Affected Workstations |
|---|---|---|---|
| GE HealthCare (Datex-Ohmeda) | 53 | 28.0% | Aisys CS2, Carestation 600/700 series, Avance |
| Dräger Medical | 30 | 15.9% | Atlan A350/A350XL, Perseus A500, Fabius |
| Getinge Group (Maquet) | 14 | 7.4% | Flow-i C30/C40, Flow-c, Flow-e |
| Mindray DS USA | 9 | 4.8% | A7, A9, V90 Vaporizers |
| Others | 83 | 43.9% | Local distributors, specialized breathing circuit and mask manufacturers |
Voluntary Corrections vs. Physical Removals
Unlike implantable devices, which are often physically removed from the hospital during a recall, anesthesia machine recalls are almost entirely voluntary corrections. These are typically resolved through manufacturer-issued software patches, updates to the Instructions for Use (IFU), or on-site component replacements performed by field service engineers. The machines are rarely removed from the facility unless a systemic structural defect is discovered.
Root Cause Analysis of Anesthesia System Recalls
Anesthesia system recalls can be categorized into several primary engineering failure modes.
1. Mechanical Ventilation Continuity and Motor Assemblies
Because the anesthesia machine acts as the patient's ventilator during general anesthesia, any interruption in mechanical ventilation represents a critical safety hazard.
The primary failure mode in this category is the unexpected cessation of ventilation. This can be caused by electronic component failures (such as loose internal cable connections that disrupt signal transmission) or mechanical failures in the ventilator motor assembly. When these failures occur, the system may enter a safe-state or sound a high-priority alarm, forcing the clinician to transition to manual ventilation using a reservoir bag.
Furthermore, failures in the drive gas delivery line can prevent the bellows or piston from compressing, resulting in hypoventilation. The complex interaction between the electronic control boards and the mechanical gas flow controllers means that software glitches can also lead to premature termination of the inhalation phase, leading to carbon dioxide retention (hypercapnia) in the patient.
2. Vaporizer Output and Anesthetic Agent Dosing
Anesthesia vaporizers are designed to deliver precise concentrations of volatile anesthetic agents (e.g., sevoflurane, desflurane, or isoflurane).
Failure modes in this category include under-dosing (leading to premature patient awakening or intraoperative awareness) or over-dosing (leading to severe cardiovascular depression or death). Root causes range from mechanical valve wear and calibration drift to software errors in electronic vaporizers that deliver agent concentrations higher than the set value.
Additionally, mechanical vaporizers rely on temp-compensation and pressure-equalization bypass valves. If these micro-valves become clogged with manufacturing particulates or agent residue, the bypass ratio shifts, resulting in unpredictable vapor output. Electronic vaporizers, which utilize digital injection valves, are susceptible to software calculations that do not account for atmospheric pressure changes, leading to over-delivery at high altitudes.
3. Breathing-Circuit and Scavenging System Failures
The patient breathing circuit is a semi-closed loop that recirculates gases while scrubbing carbon dioxide. The integrity of this loop is critical to maintain positive pressure and prevent gas leaks.
Key failure modes include cracked or broken suction switches, which can cause gas leaks or prevent the system from scavenging waste gases. Additionally, design errors that allow for the misconnection of breathing tubes can bypass safety valves, causing gas leaks or ineffective ventilation.
The Waste Anesthetic Gas Scavenging System (WAGSS) is also a critical safety point. If the scavenging system's active suction pathway becomes blocked, positive pressure can build up within the patient circuit, causing barotrauma and pulmonary edema. Conversely, excessive negative pressure in the scavenging line can suck gases away from the patient circuit, depleting the tidal volume.
4. Chemistry and Cybersecurity Risks
Modern anesthesia workstations incorporate sophisticated vaporizing chambers and networked computers, exposing them to unique chemical and software risks:
- Chemical Degradation: Incompatibilities between specific volatile agents (e.g., sevoflurane) and the plastics or metals in the vaporizing chamber can cause the agent to degrade into toxic compounds, such as hydrogen fluoride, which can corrode internal parts or be delivered to the patient.
- Cybersecurity Vulnerabilities: As networked medical devices, anesthesia workstations are susceptible to software vulnerabilities. A remote attacker could exploit these to execute arbitrary code or initiate a Denial-of-Service (DoS) attack, causing the workstation to freeze or reboot mid-procedure.
Deep Dive: MAUDE Database Signals for Anesthesia Systems
We analyzed the FDA's MAUDE database to construct a post-market safety profile for anesthesia systems. This analysis reveals a distinct reporting pattern compared to implantable devices.
2024 MAUDE Volume and Event Distribution
In 2024, MAUDE logged 6,341 device-row entries associated with anesthesia machines and vaporizers. The event type distribution is highly unique:
- Device Malfunctions: 6,302 reports (99.4% of total)
- Patient Injuries: 34 reports (0.5% of total)
- Patient Deaths: 5 reports (0.1% of total)
This distribution reflects a malfunction-dominated profile. Because anesthesia workstations are monitored continuously by anesthesiologists and incorporate extensive physiological alarms (e.g., capnography, airway pressure sensors, low-oxygen alarms), almost all device failures are detected and corrected before they cause patient harm.
For comparison, surgical heart valve MAUDE data is dominated by patient injuries (75.4%), whereas anesthesia systems convert mechanical or software failures into benign malfunctions 99.4% of the time.
2024 MAUDE Volume by Product Code
Breaking down the 6,341 reports by product code highlights that the gas machine itself is the primary source of safety reports:
| Product Code | Device Type / Clinical Family | 2024 MAUDE Reports | Percentage | Key Drivers |
|---|---|---|---|---|
| BSZ | Gas-Machine, Anesthesia | 6,067 | 95.7% | GE Carestation, Dräger Atlan, Getinge Flow-i |
| CAD | Vaporizer, Anesthesia, Non-Heated | 256 | 4.0% | Electronic and Mechanical Vaporizers |
| BZR | Mixer, Breathing Gases (Anesthesia) | 18 | 0.3% | Gas mixing manifolds and blenders |
Notable Class I and High-Acuity Anesthesia Machine Recalls
Several recalls have had a significant impact on clinical practice. The table below summarizes these key events:
| Manufacturer & Model | Recall Date | Product Code | FDA Class | Affected Units | Failure Mode | Clinical Consequences |
|---|---|---|---|---|---|---|
| GE Carestation 600 | February 2020 | BSZ | Class I | ~3,600 | Loose internal cable connection. | 0 injuries/deaths; cable could disconnect, halting mechanical ventilation mid-procedure. |
| GE Carestation 600/700 | December 2025 | BSZ | Class I | Multiple | Use-instruction correction. | Outlined steps to prevent ineffective ventilation during specific gas supply failures. |
| GE Carestation VCV Mode | April 2025 | BSZ | Class I | Multiple | Software error in Volume Control Ventilation. | Ineffective ventilation in VCV mode; required software patch. |
| Dräger Atlan A350 / A350XL | June 2026 | BSZ | Class I | Multiple | Ventilator-motor-assembly failure. | 0 injuries/deaths; motor failure could stop ventilation. Dräger advised manual ventilation. |
| Getinge Flow-c / Flow-e | June 2022 | BSZ | Class I | Multiple | Cracked or broken suction on/off switches. | Gas leaks or loss of scavenging suction; required replacement of the switch assembly. |
| Getinge / Maquet Flow-i | April 2024 | BSZ | Class I | Multiple | Sevoflurane degradation to hydrogen fluoride. | Corrosion of internal components and delivery of toxic compounds to patient; required chamber redesign. |
| Getinge Flow Workstations | September 2024 | BSZ | Class II | Multiple | Cybersecurity Denial-of-Service (DoS) vulnerability. | Network vulnerability could allow remote attack to freeze or reboot the machine. |
| Mindray V90 Vaporizer | September 2024 | CAD | Class II | Multiple | Anesthetic output higher than set concentration. | Software error caused vaporizer to deliver excess agent, leading to cardiovascular depression. |
| Datex-Ohmeda (GE) | October 2024 | BSZ | Class II | Multiple | Breathing circuit misconnection. | Risk of tube misconnection, causing gas leaks or loss of positive pressure. |
Case Study 1: Dräger Atlan A350 Ventilator-Motor Recall (2026)
In June 2026, the FDA classified Dräger's correction for its Atlan A350 and A350XL anesthesia workstations as a Class I recall. The root cause was identified as a manufacturing defect in the ventilator-motor assembly. Under certain conditions, the motor could fail, halting mechanical ventilation.
Dräger reported 0 injuries and 0 deaths. The manufacturer advised clinicians that if a motor failure occurred, the machine would sound a high-priority alarm. Clinicians were instructed to immediately switch to manual ventilation using the auxiliary bag circuit while a replacement motor was installed. This recall demonstrates how mechanical ventilation continuity drives Class I status, even when alarms successfully prevent patient injury.
Case Study 2: GE Carestation 600 Series Loose Cable (2020)
In early 2020, GE HealthCare initiated a Class I recall for approximately 3,600 Carestation 600 series workstations. The recall was triggered by reports of loose internal cable connections that could disconnect during movement, causing an immediate loss of mechanical ventilation.
Like the Dräger event, no patient injuries or deaths were reported because the workstation's alarms functioned correctly, allowing anesthesiologists to transition to manual ventilation. GE resolved the issue by deploying field service engineers to secure the cable connections, illustrating that physical design stability is as critical as software reliability.
Case Study 3: Getinge Flow-i Sevoflurane Degradation (2024)
In April 2024, Getinge (Maquet) issued a major correction for its Flow-i workstations due to a chemical interaction. The company discovered that under specific humidity and temperature conditions, sevoflurane could degrade within the vaporizing chamber, generating hydrogen fluoride.
Hydrogen fluoride is highly corrosive and could damage the machine's internal flow sensors or be delivered to the patient's breathing circuit, causing airway irritation. Getinge resolved the issue by updating the chamber's materials and revising the drying protocols for the breathing circuit, showing how chemical compatibility must be integrated into OR safety evaluations.
Actionable Playbook for Healthcare Technology Management (HTM) & Risk Managers
HTM and clinical engineering departments can utilize post-market safety data to optimize OR operations and procurement.
1. Integrate Cybersecurity into Anesthesia Procurement
With the FDA's enforcement of section 524B of the FD&C Act, manufacturers must provide cybersecurity updates for new devices. As demonstrated by the Getinge DoS vulnerability in 2024, anesthesia machines are network-connected targets.
HTM teams must review the manufacturer's Software Bill of Materials (SBOM) and ensure that anesthesia systems are placed on isolated VLANs with strict firewall rules. For a detailed comparison of cybersecurity frameworks, see our comparison of FDA and EU medical device cybersecurity requirements.
2. Standardize Pre-Use Checklist Protocols
Because 99.4% of anesthesia safety events in MAUDE are captured as malfunctions before causing injury, the pre-use checklist is the hospital's most effective defense. HTM departments should coordinate with anesthesiology leadership to enforce the FDA's Anesthesia Apparatus Checkout Recommendation before the first case of the day. This checklist verifies pressure checks, circuit integrity, and alarm function.
3. Maintain Vendor-Specific Spares for High-Failure Components
Based on the recall record, HTM departments should maintain stock of components prone to wear or failure, such as the Getinge suction switch assembly or Datex-Ohmeda breathing circuit adaptors. Having these parts on hand reduces downtime and prevents the need to take a room out of service.
4. Cross-Reference Manufacturer Footprints
When planning capital equipment cycles, analyze the manufacturer's overall regulatory footprint. For example, comparing GE's recall history against Baxter's FDA device footprint provides valuable insight into vendor quality control, helpfully informing long-term service contract negotiations.
Sibling Recalls: How Anesthesia Systems Compare to Other Respiratory Devices
To understand the broader respiratory safety landscape, compare anesthesia machine safety against other device classes:
- ICU and Transport Ventilators: The ventilator recall Class I MAUDE analysis highlights a safety profile driven by acute software crashes, power management failures, and sensor drift in ICU ventilators. Anesthesia systems share these ventilator failure modes but incorporate additional complexity via the vaporizer and scavenging systems.
- Infusion Pumps: The infusion pump Class I recall root-cause analysis centers on battery failures, software calculation bugs, and physical latch cracks. Like anesthesia machines, infusion pump safety relies heavily on clinical alarms to prevent patient harm.
- Electrosurgical Units (ESUs): The electrosurgical unit (ESU) recall teardown focuses on surgical fire risks and electrical insulation failures, representing a different set of OR hazards than gas delivery and ventilation continuity.
Frequently Asked Questions (FAQs)
What is the most recent FDA Class I anesthesia machine recall?
The most recent major Class I event is the Dräger Atlan A350 and A350XL recall classified in June 2026, which was triggered by a ventilator-motor assembly failure that could halt mechanical ventilation. Prior to this, the GE Carestation 600/700 series recall in December 2025 addressed use-instruction corrections to prevent ineffective ventilation during gas supply failures.
Why do anesthesia gas machines (BSZ) dominate the recall and MAUDE numbers?
Anesthesia gas machines (product code BSZ) are the physical workstations that house the ventilator, flow sensors, breathing circuit, gas blenders, and electronic controls. Because the workstation serves as the central hub, any component failure—even in an accessory—is typically reported under the main machine's product code. Vaporizers (code CAD) are separate modules and represent a smaller share of reports.
How do anesthesia recalls differ from ventilator recalls?
Anesthesia machine recalls are more complex. While ventilator recalls focus on airway pressure control, battery backup, and sensor reliability, anesthesia recalls must also account for anesthetic agent delivery (vaporizer dosing accuracy), gas scavenging (preventing OR pollution), chemical degradation (sevoflurane interactions), and complex gas mixing controls.
Have cybersecurity vulnerabilities triggered anesthesia-device recalls?
Yes, in September 2024, Getinge's Flow workstations were subject to a Class II recall due to a Denial-of-Service (DoS) vulnerability. If exploited, the vulnerability could allow an attacker to disrupt communication or cause the workstation to reboot, representing a real-world example of how cybersecurity risks affect active life-support systems in the OR.
How does the FDA classify software-only anesthesia machine modifications?
The FDA regulates software-only updates and modifications based on whether they introduce new clinical functions or alter ventilation control logic. Under product code QSF (Software, Gas-Machine, Anesthesia), modifications that automate physiological closed-loop delivery or adjust lung-protective algorithms require a new 510(k) pre-market notification or a PMA supplement. Minor GUI changes or network security updates can typically be managed under internal quality system change control.
Sources
- FDA Anesthesia Correction Notice — GE Carestation (2025): https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/anesthesia-system-correction-ge-healthcare-updates-use-instructions-carestation-anesthesia-systems
- FDA Anesthesia Machine Recall — Draeger Atlan (2026): https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/anesthesia-machine-correction-draeger-inc-issues-correction-atlan-a350-and-a350xl-anesthesia
- FDA Class I Recall — GE Carestation VCV Mode (2025): https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/anesthesia-delivery-systems-recall-ge-healthcare-issues-correction-certain-carestations-due-risk
- MedTech Dive — GE Anesthesia Recall Analysis: https://www.medtechdive.com/news/fda-puts-high-risk-label-on-ge-healthcare-anesthesia-systems-recall/571992
- FDA Recall Database Entry — GE Aisys (res.cfm): https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144046
- Healthcare Brew — FDA Device Recalls: https://www.healthcare-brew.com/stories/2024/12/04/recall-roundup-fda-medical-device-recalls-during-november
- Detroit Anesthesia Services — Recalls: https://detroitanesthesiaservices.com/recalls-of-anesthesia-machines/
- FDA Cybersecurity Guidance: medical device cybersecurity requirements compared (FDA vs EU)
- GE HealthCare Footprint Context: Baxter FDA device footprint
- ICU Ventilator Safety Context: ventilator recall Class I MAUDE analysis