GE Healthcare Recalls Brivo XR285amx Mobile X-Ray Units
GE Healthcare is recalling six Brivo XR285amx mobile X-ray units in the US due to potential inaccuracies in mAs accuracy checks.
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 3/5 (High).
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 criteria for a High severity score.
Plain-English summary
GE Healthcare is recalling six units of the Brivo XR285amx Automatic Mobile X-Ray (AMX) Series. The recall affects units distributed in the United States to the states of Arizona, Florida, Georgia, Missouri, and Wisconsin. The specific product codes are BrivoXR285amx - PN 5555000 and 5555000-2.
The recall was initiated because an issue was identified with the mAs accuracy check performed on the system. This defect could result in inaccuracies in the 10% to 20% range for exposure times longer than 15 milliseconds. The FDA has classified this recall as Class II, indicating that use of the product could cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Healthcare facilities and consumers who possess these specific units should contact GE Healthcare for further instructions on how to resolve the issue. The source text does not report any illnesses or injuries associated with this defect.
The recalled product
- Product
- GE Healthcare Automatic Mobile X-Ray (AMX) Series: Brivo XR285amx
- 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)
- BrivoXR285amx - PN 5555000
- 5555000-2
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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