GE Healthcare Recalls Mobile X-Ray Units Due to Software Issue
GE Healthcare is recalling Optima XR200amx and XR22Oamx mobile X-ray units 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, but the source text does not report any injuries, illnesses, or specific safety hazards, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
GE Healthcare, LLC is recalling the Optima XR200amx with Digital Upgrade and the Optima XR22Oamx mobile radiographic products. The recall is due to a software issue identified on the interface of these devices.
The affected products are part of the GE Automatic Mobile X-Ray (AMX) Series. These devices are intended to take exposures utilizing film or computed radiography (CR), with the Optima XR22Oamx utilizing the GE Wireless Detector for digital radiography. A total of 217 units were installed in the United States, with nationwide distribution.
The source text does not specify the exact nature of the software failure or the specific corrective actions consumers or healthcare providers should take beyond the recall notice. Users of these devices should contact GE Healthcare for further instructions.
The recalled product
- Product
- GE Healthcare Optima XR 200 amx with Digital Upgrade. 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 Wireless
- Manufacturer
- GE Healthcare, LLC
- 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 - 5421698
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.
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