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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Device
Medical Devices/Monitoring Devices

Draeger Medical, Inc.: Perseus A500 Anesthesia Workstations Recalled for Unexpected Shutdown

Agency Publication Date: April 18, 2024
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Summary

Draeger Medical is recalling 16,841 Perseus A500 Anesthesia Workstations because the devices can shut down unexpectedly while operating on battery power. This critical failure can occur without warning, immediately stopping the delivery of anesthesia and ventilation to patients. This recall affects workstations distributed nationwide and internationally; the company has initiated the recall via notification letters to affected facilities.

Risk

An unexpected shutdown of an anesthesia workstation during a procedure can cause an immediate loss of patient ventilation and anesthesia delivery. This poses a life-threatening risk of respiratory failure, brain injury due to lack of oxygen, or the patient regaining consciousness during surgery.

What You Should Do

  1. Identify your device by checking for the Dräger Perseus A500 Anesthesia Workstation label. Confirm your device is affected by matching Material Number MX06000 and UDI-DI 04048675253600.
  2. Check the serial number on the back or side of the workstation; this recall applies to all serial numbers for the MX06000 material version.
  3. Ensure the workstation remains connected to a reliable main power supply (wall outlet) at all times to prevent reliance on the battery system until a permanent fix is implemented.
  4. Contact your healthcare provider or Draeger Medical, Inc. immediately to confirm receipt of the recall notification and to receive specific technical instructions or updates regarding the battery software or hardware.
  5. If you have additional questions, contact the FDA's medical device recall line at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

📋Other Action

Manufacturer Notification and Guidance

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Dräger Perseus A500 Anesthesia Workstation
Model / REF:
MX06000
UDI-DI: 04048675253600
Lot Numbers:
All Serial Numbers

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94269
Status: Active
Manufacturer: Draeger Medical, Inc.
Sold By: hospital distributors; medical equipment suppliers
Manufactured In: United States
Units Affected: 16,841 units
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.