Optima XR200amx. Mobile general purpose radiographic recall: Software Issue
Optima XR200amx. Mobile general purpose radiographic imaging of the human head and body.
Why was Optima XR200amx. Mobile general purpose radiographic recalled?
Software issue: a violation of 21 CFR 1020.31(a). After an image is taken, when the user selects and clears an additionally displayed screen the system inhibit is also cleared, allowing the user to take an exposure without the technique factors being displayed.
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: 5555000-3, 5555000-4, 5555000-5, 5555000-6.
- Product
- Optima XR200amx. Mobile general purpose radiographic imaging of the human head and body.
- Recalling firm
- GE Healthcare, LLC
- Quantity
- 254 total in the US
- Distribution
- Worldwide Distribution -- USA (nationwide) Distribution
- Recall date
- September 19, 2012
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)