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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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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

Philips EPIQ Ultrasound Systems Recalled for Reboot and Transducer Damage

Agency Publication Date: December 31, 2025
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Summary

Philips Ultrasound, LLC has recalled 1,721 Philips EPIQ Ultrasound Systems (various models) when used with the X5-1c transducer. The affected systems, running software versions 9.0, 9.01, or 9.02, may experience an unexpected automatic reboot during medical procedures. While no injuries have been reported, this malfunction can result in physical damage to the connected transducer.

Risk

The ultrasound system can reboot without warning, which may interrupt diagnostic procedures and cause permanent damage to the X5-1c transducer.

What You Should Do

  1. This recall affects Philips EPIQ Ultrasound Systems running software versions 9.0, 9.01, and 9.02 when used in conjunction with X5-1c transducers.
  2. Check your system's software version and identifying REF numbers (795117, 795122, 795200, 795201, 795231, 795232, or 795234) to determine if your unit is affected. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled device.
  4. Contact Philips Ultrasound, LLC or your distributor to arrange for a software update, repair, or system correction.
  5. Call the FDA Consumer Complaint hotline at 1-888-463-6332 (1-888-INFO-FDA) for additional questions regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Philips EPIQ Ultrasound Systems
Variants: Software Version 9.0, Software Version 9.01, Software Version 9.02, Used with X5-1c transducer
Model / REF:
795200
795201
795231
795232
795234
795117
795122
UDI:
00884838107540
00884838107533
00884838097933
00884838047693
00884838107441

Quantity: 1,721 systems affected.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98102
Status: Resolved
Manufacturer: Philips Ultrasound, LLC
Sold By: Philips Ultrasound, LLC
Manufactured In: United States
Units Affected: 1,721 systems
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 ยท 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.