System INFX-8000V recall
System INFX-8000V
Why was System INFX-8000V recalled?
The x-ray irradiation field may shift with respect to image receiving surface displayed on the screen at some C-arm angles.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA 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: CAS-880A, CAS-830B
- Product
- System INFX-8000V
- Recalling firm
- Canon Medical System, USA, INC.
- Quantity
- 272 in total
- Distribution
- Nationwide
- Recall date
- March 17, 2021
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)