GE Healthcare Automatic Mobile X-Ray recall
GE Healthcare Automatic Mobile X-Ray (AMX) Series: Optima XR200 amx
Why was GE Healthcare Automatic Mobile X-Ray recalled?
An issue was identified with the mAs accuracy check performed on the system that could result in inaccuracies in the 10% to 20% range for exposure times longer than 15 msec.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
OptimaXR200amx PN 5555000-3, PN5555000-4
- Product
- GE Healthcare Automatic Mobile X-Ray (AMX) Series: Optima XR200 amx
- Recalling firm
- GE Healthcare
- Quantity
- 6 units in US
- Distribution
- US Distribution to the states of: AZ, FL, GA, MO and WI.
- Recall date
- May 6, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)