The Recall Desk
ModerateFDA (Devices)·Z-0449-2013·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 interface.

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, which typically involves a temporary or medically reversible adverse health consequence. Since no specific injuries, illnesses, or deaths are reported in the source text, and the issue is described as a software interface problem without explicit mention of high-risk pathogens or structural defects, it falls under the Moderate category as a precautionary or low-risk contamination/defect scenario.

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, which includes the Brivo XR2S5amx, Optima XR200amx, and Optima XR220amx. These systems are intended to take exposures utilizing film or computed radiography (CR), with the Optima XR220amx utilizing the GE Wireless Detector for digital radiography (DR). A total of 217 units are installed in the US, with nationwide distribution.

The source text does not specify the exact nature of the software issue, the potential impact on patient safety, or specific instructions for consumers or healthcare providers on how to proceed. Users of these devices should contact GE Healthcare for further information regarding the recall and any necessary corrective actions.

The recalled product

Product
GE Healthcare Optima XR 220amx 15kw 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 Wireles
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 - 5555000-6

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 →

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