The Recall Desk
ModerateFDA (Devices)·Z-0725-2014·Announced 2014-01-22

GE Healthcare Recalls Mobile X-ray Systems Due to Software Display Issue

GE Healthcare is recalling 1,027 Optima XR220amx and XR200amx mobile X-ray systems due to a software issue that may cause patient exams to display incorrectly.

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: The recall is classified as FDA Class II, but the source text describes a software display issue without reporting any injuries, hospitalizations, or deaths, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

GE Healthcare, LLC is recalling 1,027 units of the Optima XR220amx and Optima XR200amx with Digital Upgrade Mobile Radiographic Systems. The affected model numbers are 5555000-5, 5555000-6, and 5421698. The recall covers units distributed worldwide, including the United States, Washington D.C., Guam, and numerous international locations.

The recall is due to a software issue associated with patient selection from the worklist. Intermittently, when a large number of patient exams are retrieved from the HIS/RIS system, the exams may not be properly displayed on the mobile X-ray system. If a user continues to attempt to select one of the exams, the system may not function as intended.

Healthcare facilities should contact GE Healthcare for instructions on how to resolve the software issue. No specific injuries or illnesses have been reported in the source text.

The recalled product

Product
GE Optima XR220amx and Optima XR200amx with Digital Upgrade Mobile Radiographic Systems. Model numbers 5555000-5, 5555000-6, and 5421698.
Manufacturer
GE Healthcare, LLC
Category
Medical Device — Mobile X-ray Systems
Hazard
Affected units
1,027

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)

  • Serial Numbers: 00000002796EN1
  • 00000002797EN9
  • 00000002798EN7
  • 00000002799EN5
  • 00000002800EN1
  • 00000002801EN9
  • 00000102726WK9
  • 00000102789WK3
  • 00000102937WK7
  • 00000130778WK3
  • 00000UA45526-8
  • 00001027058WK5
  • 00001027061WK9
  • 00001027146WK8
  • 00001027149WK2
  • 00001027150WK0
  • 00001027151WK8
  • 00001027153WK4
  • 00001027154WK2
  • 00001027167WK4

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

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