GE Proteus XR/A radiographic system Wall Stand cable maintenance recall
GE Healthcare is recalling certain Proteus XR/A radiographic systems because steel cables in the Wall Stand component have not been replaced at manufacturer-specified maintenance intervals.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a Class II device recall with no reported injuries or incidents. The issue is a preventative maintenance compliance matter where cables have not been replaced at specified intervals. The hazard is theoretical—cable degradation or failure—without any documented harm.
Plain-English summary
The GE Proteus XR/A radiographic system is being recalled due to maintenance compliance issues. Specifically, steel cables in the Wall Stand component have not been replaced at the intervals detailed in the manufacturer's Preventative Maintenance Action List.
This issue affects approximately 956 systems distributed worldwide with US nationwide distribution. The failure to replace cables at specified intervals could result in cable degradation over time.
Users of affected systems should contact GE Healthcare to schedule cable replacement according to the Preventative Maintenance Action List. GE Healthcare recommends compliance with all specified maintenance intervals to ensure equipment safety and proper operation.
The recalled product
- Product
- GE Proteus XR/A radiographic system
- Manufacturer
- GE Healthcare (China) Co., Ltd.
- Affected units
- 956
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 (1)
- UDI-DI: 00840682120777
Distribution
Distributed nationwide across the United States.
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