GE Healthcare Optima Mobile X-ray System. The GE recall: Software Issue
GE Healthcare Optima Mobile X-ray System. The GE Automatic Mobile X-Ray (AMX ) Series are intended to take exposures utilizing film or computed…
Why was GE Healthcare Optima Mobile X-ray System. The GE recalled?
GE Healthcare has become aware of a software issue on the interface of the mobile radiographic product, Optima XR200amx, ond Optima XR220amx related to Visual indication as mandated by the US Code of Federal Regulations (21CFR) and IEC 60601-1-3.
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?
Model Numbers Optima XR200 15kw Optima XR 200 30kw Optima XR 220 15kw Optima XR 220 30kw
- Product
- GE Healthcare Optima Mobile X-ray System. The GE Automatic Mobile X-Ray (AMX ) Series are intended to take exposures utilizing film or computed…
- Recalling firm
- GE Healthcare, LLC
- Quantity
- 254 units have been shipped to/installed in the U.S.
- Distribution
- Worldwide Distribution (USA) nationwide
- Recall date
- July 25, 2012
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)