GE Healthcare Proteus XR/a X-Ray System Missing De-Installation Manual
GE Healthcare's Proteus XR/a stationary X-ray system lacks a required de-installation manual, creating risk of personnel injury during device removal.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a risk-of-harm product where injury has not yet been reported. The missing de-installation manual creates potential for personnel injury during device removal without proper procedural guidance, fitting the High (3) tier per the rubric.
Plain-English summary
GE Healthcare Proteus XR/a stationary X-ray systems (3,572 units distributed worldwide) do not include a de-installation manual that describes the process steps required to safely remove these devices. Proper de-installation procedures must be followed to prevent personnel injuries during the de-installation process.
Healthcare facilities and organizations operating these systems should obtain the de-installation manual from GE Healthcare before attempting to remove or de-install any units. The absence of proper de-installation instructions creates a risk of injury to personnel responsible for device removal.
The recalled product
- Product
- GE Healthcare Proteus XR/a, stationary X-Ray System, Model/Catalog Numbers: 1) 2259973; 2) 2259988; 3) 2266999; 4) 2373519; 5) 2379827; 6) 5729352; 7) 2259973-1; 8) 2259973-2; 9) 2259973-3; 10) 2259973-4; 11) Not Available
- Manufacturer
- GE Healthcare (China) Co., Ltd.
- Affected units
- 3,572
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 1) 2259973: UDI/DI none: System ID Numbers: 918485PROT1
- 281410PRO
- UDI/DI 00840682120777: System ID Number 503315PRO
- 2) 2259988: UDI/DI 00840682106139: System ID Numbers: 305682PROTEUS
- 305MCPCPRO
- 828262PROT
- 631376ER2
- 716675DPRO1
- 206965XR
- UDI/DI 00840682120777: System ID Numbers: 251435PROT
- 334418PRO
- 334418XRA
- 520MERPRO
- 805652DR2
- 303320TPXR
- 970248PROT
- 203732PROT
- 203876XRA564
- 941792PROTEUS
- 305CGHPROTEUS
Distribution
Distribution scope not specified by the agency.
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