The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0448-2013·Announced 2012-12-05

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

GE Healthcare is recalling Optima XR220amx and XR200amx mobile X-ray systems due to a software issue on the product interface.

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 does not report any injuries, illnesses, or specific safety hazards, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

GE Healthcare, LLC is recalling the Optima XR220amx and Optima XR200amx mobile X-ray systems with Digital Upgrade. The recall is due to a software issue identified on the interface of these mobile radiographic products.

The affected units are part of the GE Automatic Mobile X-Ray (AMX) Series and are intended for taking exposures utilizing film or computed radiography (CR). The Optima XR220amx utilizes the GE Wireless Detector for digital radiography. A total of 217 units were installed in the United States.

The source text does not specify the exact nature of the software defect or the specific corrective actions required. Users of these devices should contact GE Healthcare for further instructions regarding the software issue.

The recalled product

Product
GE Healthcare Optima XR 220amx 30kw Mobile X-ray System The GE Automatic Mobile X-Ray (AMX) Series: Brivo XR2S5amx, Optima XR200amx, Optima XR22Oamx are intended to take exposures utilizing film or computed radiography (CR), however the Optima XR22Oamx utilizes the GE…
Manufacturer
GE Healthcare, LLC
Category
Medical Device — Imaging Equipment
Hazard
Affected units
217

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)

  • Model No - 5555000-5

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by GE Healthcare, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Related recalls

Same manufacturer · GE Healthcare, LLC

See all →

Same hazard · software defect

See all →

Similar recalls