The Recall Desk
ModerateFDA (Devices)·Z-0550-2025·Announced 2024-12-04

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.

What this means for you

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.
Hazard
  • cable-degradation
  • maintenance-failure

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.