GE Healthcare Recalls Optima XR200 amx Mobile X-Ray Units
GE Healthcare is recalling six Optima XR200 amx mobile X-ray units in the US due to potential mAs accuracy issues that may affect exposure times.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
GE Healthcare is recalling six units of the Optima XR200 amx Automatic Mobile X-Ray (AMX) Series in the United States. The recall involves units distributed to the states of Arizona, Florida, Georgia, Missouri, and Wisconsin.
The recall is due to an identified issue with the mAs accuracy check performed on the system. This issue could result in inaccuracies in the 10% to 20% range for exposure times longer than 15 milliseconds. The affected units are identified by part numbers 5555000-3 and 5555000-4.
This recall is classified as Class II by the FDA. Consumers and healthcare facilities should contact GE Healthcare for further instructions regarding the affected equipment.
The recalled product
- Product
- GE Healthcare Automatic Mobile X-Ray (AMX) Series: Optima XR200 amx
- Manufacturer
- GE Healthcare
- Hazard
- Affected units
- 6
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 (2)
- OptimaXR200amx PN 5555000-3
- PN5555000-4
Distribution
Part of a larger recall action
This product is one of 3 recalled by GE Healthcare 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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