GE Healthcare Optima XR 220amx Mobile general purpose recall
GE Healthcare Optima XR 220amx Mobile general purpose radiographic imaging of the human head and body.
Why was GE Healthcare Optima XR 220amx Mobile general purpose recalled?
It was discovered GE Healthcare has become aware of a firmware issue on the mobile radiographic product, Brivo XR285amx, Optima XR200amx, Optima XR22Oamx and Optima XR200amx with Digital Upgrade, related to Technique Accuracy as mandated by the US Code of Federal Regulations (21CFR) and IEC 60601-2-54.
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?
part numbers: 5555000-5, 5555000-6
- Product
- GE Healthcare Optima XR 220amx Mobile general purpose radiographic imaging of the human head and body.
- Recalling firm
- GE Healthcare, LLC
- Quantity
- 364 total units installed in US
- Distribution
- Nationwide Distribution
- Recall date
- November 28, 2012
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)