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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

GE Proteus XR/A Radiographic Systems Recalled for Failed Cable Maintenance

Agency Publication Date: November 25, 2024
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Summary

GE Healthcare (China) Co., Ltd. is recalling 956 Proteus XR/A radiographic systems because steel cables in the wall stand were not replaced at the required safety intervals. These units were serviced by GE HealthCare but missed the necessary cable replacements detailed in the system's maintenance schedule. While no incidents or injuries have been reported, failing to replace these support cables could lead to mechanical failure of the equipment. Facilities should stop using affected units and contact the manufacturer or an authorized distributor to arrange for required servicing and cable replacement.

Risk

If the steel cables in the wall stand are not replaced according to schedule, they may weaken and snap over time. This could cause heavy equipment components to fall suddenly, potentially causing impact injuries to patients or healthcare staff.

What You Should Do

  1. This recall affects GE Proteus XR/A radiographic systems with UDI-DI 00840682120777 and specific System IDs.
  2. Identify your unit by checking the System ID label on the device. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled device immediately.
  4. Contact GE HealthCare or your authorized medical equipment distributor to schedule the required maintenance and cable replacement.
  5. Call the FDA Consumer Complaint hotline at 1-888-463-6332 (1-888-INFO-FDA) for additional questions regarding this medical device 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: GE Proteus XR/A radiographic system
Serial Numbers (955):
907443PROTEUS
251847RAD
256737PRO
251435PROT
251275RAD
251275RAD2
256486XR1
256429CR2
334732PXRA
256332RRM1
334418PRO
334418XRA
334670RAD
256487RAD
870898PROT
479BVXR
870541PROT6
870226PROT
870208RF
870208XR1
520498PR1
520498PR2
520901GERF1
928348PRO
928348PRO2
520MERPRO
RADNETRAD352
310888PRO
818563DR
818461DR
707421NBSDI1
510797RM1
714537RM3
801774ER
909336RAD1
909336RAD2
760379RAD
213744PROTXR1
213744PROTXR2
310825PRO2
925370ORTHO1
925370ORTHO2
AVHRD22776
818360XR1
310374PRO
909788R2
831424RAD2
408885EDB
562493RM1
805418XR1
UDI:
00840682120777

Units were not replaced at maintenance intervals detailed in the Preventative Maintenance Action List.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95674
Status: Active
Manufacturer: GE Healthcare (China) Co., Ltd.
Sold By: GE HealthCare; Authorized medical equipment distributors
Manufactured In: China
Units Affected: 956 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.