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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 Healthcare (China) Co., Ltd.: Proteus XR/a X-Ray Systems Recalled Due to Missing De-installation Manual

Agency Publication Date: August 26, 2024
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Summary

GE Healthcare (China) Co., Ltd. has recalled 3,572 Proteus XR/a stationary X-Ray systems because they were distributed without a de-installation manual. Without these specific step-by-step instructions, service personnel or technicians may perform the de-installation incorrectly, which can lead to physical injury during the removal process. These professional medical devices were manufactured in China and distributed worldwide. If you are a healthcare provider using this system, contact the manufacturer to obtain the necessary safety documentation before attempting any equipment removal.

Risk

The lack of proper de-installation instructions creates a physical hazard where technicians may accidentally release mechanical tension or encounter heavy components unexpectedly, leading to serious personnel injury during the de-installation process.

What You Should Do

  1. Identify if your stationary X-Ray system is affected by checking the Model/Catalog numbers: 2259973, 2259988, 2266999, 2373519, 2379827, 5729352, 2259973-1, 2259973-2, 2259973-3, or 2259973-4.
  2. Locate your System ID Number or UDI/DI (such as 00840682120777 or 00840682106139) on the device's identification plate to confirm it is part of the 3,572 affected units.
  3. Do NOT attempt to de-install, move, or dismantle the Proteus XR/a system until you have received the official de-installation manual from GE Healthcare.
  4. Contact GE Healthcare (China) Co., Ltd. or your local GE Healthcare service representative to request the missing de-installation instruction process steps.
  5. If you are a healthcare provider, consult with your facility's biomedical engineering department or the manufacturer regarding the safety of your specific unit.
  6. For additional questions or to report an issue, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Provision of missing de-installation manual

How to: Contact your healthcare provider or the manufacturer GE Healthcare for the missing de-installation instruction process steps to avoid personnel injury.

Affected Products

Product: GE Healthcare Proteus XR/a stationary X-Ray System (Model 2259973)
Model / REF:
2259973
Lot Numbers:
System ID: 918485PROT1
System ID: 281410PRO
System ID: 503315PRO
Product: GE Healthcare Proteus XR/a stationary X-Ray System (Model 2259988)
Model / REF:
2259988
Lot Numbers:
System ID: 305682PROTEUS
System ID: 305MCPCPRO
System ID: 828262PROT
System ID: 631376ER2
System ID: 716675DPRO1
System ID: 206965XR
System ID: 251435PROT
System ID: 334418PRO
System ID: 334418XRA
System ID: 520MERPRO
System ID: 805652DR2
System ID: 303320TPXR
Product: GE Healthcare Proteus XR/a stationary X-Ray System (Model 2266999)
Model / REF:
2266999
Lot Numbers:
System ID: 616392WDR1
Product: GE Healthcare Proteus XR/a stationary X-Ray System (Model 2373519)
Model / REF:
2373519
Lot Numbers:
System ID: 631376ER1
System ID: 310374PRO
System ID: 3026293
System ID: FHORLER4
System ID: TAMXERDR01
System ID: 517353PROTEUS
Product: GE Healthcare Proteus XR/a stationary X-Ray System (Model 2379827)
Model / REF:
2379827
Lot Numbers:
System ID: 218387PROT
System ID: 702634XR
System ID: 812442XRA
System ID: 913396XRA
Product: GE Healthcare Proteus XR/a stationary X-Ray System (Model 5729352)
Model / REF:
5729352
Lot Numbers:
System ID: DENQUIXR1
System ID: 229259OUTFP
System ID: 252209DIG3
System ID: 703849RAD1WDR
System ID: 509967CEX1
Product: GE Healthcare Proteus XR/a stationary X-Ray System (Model 2259973-1)
Model / REF:
2259973-1
Lot Numbers:
System ID: 207795MCHP
System ID: 717SHCR2
System ID: 281SJCPRO2
System ID: 281SJCPRO3
System ID: 281SJCPRO
Product: GE Healthcare Proteus XR/a stationary X-Ray System (Model 2259973-2)
Model / REF:
2259973-2
Lot Numbers:
System ID: 256705XR1
System ID: DAZGHGILXR
System ID: 303FCAUSHXR
System ID: 719264RAD
System ID: 720745XR
Product: GE Healthcare Proteus XR/a stationary X-Ray System (Model 2259973-3)
Model / REF:
2259973-3
Lot Numbers:
System ID: 310888PRO
System ID: 626381PROTEUS
System ID: 720CRHIXR
System ID: 303365XR
System ID: 860224PROT
Product: GE Healthcare Proteus XR/a stationary X-Ray System (Model 2259973-4)
Model / REF:
2259973-4
Lot Numbers:
System ID: 704323PROH
System ID: 720627XRA
System ID: FHAPKPRO2
System ID: 813916XRA

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95222
Status: Active
Manufacturer: GE Healthcare (China) Co., Ltd.
Sold By: GE Healthcare; Authorized medical device distributors
Manufactured In: China
Units Affected: 3572 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.

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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.