System recall
System Model: Ultimax-i, DREX-UI80 (DREX-UI80); Unit Model: HDR-08A Imager Processor; UDI (01)04987670100147
Why was System recalled?
During a procedure, when images were acquired, and these images were transferred to PACS /image archival system, the number of images displayed were not the same as originally acquired.
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?
The following serial numbers are affected: U4D1992027, U4D19X2029, U4D19Y2030, U4D19Y2031, U4D19Y2033, U4E2012035, U4E2012036, U4E2022037, U4D19Y2032, U4E19Z2034 and U4E2032041.
- Product
- System Model: Ultimax-i, DREX-UI80 (DREX-UI80); Unit Model: HDR-08A Imager Processor; UDI (01)04987670100147
- Recalling firm
- Canon Medical System, USA, INC.
- Quantity
- 11 units
- Distribution
- US - CA, CT, ID, LA, MT, NV, OH, SC, WI and WV
- Recall date
- September 2, 2020
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)