Agency classClass IIOur severity:Moderate FDA (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.

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: 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: software-defect
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:

Same manufacturer · GE Healthcare, LLC

See all →

High
GE SIGNA Premier MRI magnets may have ferrous fittings fitted
FDA (Devices) · 2026-04-08
High
GE Medical Imaging Software: Inaccurate Measurements in Global Stack Viewport
FDA (Devices) · 2022-08-31
High
GE Healthcare CT, PET, and NM Patient Tables May Drop During Service
FDA (Devices) · 2022-08-17
High
GE Centricity PACS Software fails to notify of exam study modifications
FDA (Devices) · 2022-08-03
Severe
GE Healthcare Anesthesia Systems Recalled for Potential Transducer Connection Reversal
FDA (Devices) · 2022-07-27

Same hazard · software defect