INFX-8000V. For radiographic and fluoroscopic studies recall
INFX-8000V. For radiographic and fluoroscopic studies and intervention.
Why was INFX-8000V. For radiographic and fluoroscopic studies recalled?
The fluoroscopic dose rate might exceed the conforming value during biplane fluoroscopy.
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: Alphenix i with software version 8.0, 9.0 or 9.2 and the TFP 1200C FPD.
- Product
- INFX-8000V. For radiographic and fluoroscopic studies and intervention.
- Recalling firm
- Canon Medical System, USA, INC.
- Quantity
- 16 systems
- Distribution
- US Nationwide Distribution
- Recall date
- September 7, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)