Recall Z-2885-2020 ยท OWB Interventional Fluoroscopic X-Ray System
Canon Medical System, USA, INC.
System Model: Ultimax-i, DREX-UI80 (DREX-UI80); Unit Model: HDR-08A Imager Processor; UDI (01)04987670100147
| Date | Jul 8, 2020 |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Software design |
| Action | The recall letters were sent via facsimile between 07/08-10/2020. The letter contains a return reply form that is to be completed by the customer and faxed to CMSU for retention. After approximately one month contact will be made with each non-responding location and a copy of the letter will be faxed to that location and the fax receipt will serve as proof of notification. |
| Quantity | 11 units |
| Distribution | US - CA, CT, ID, LA, MT, NV, OH, SC, WI and WV |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K181834 | Ultimax-i, DREX-UI80 (V1.60) Canon Medical Systems Corporation, Jul 19, 2018 |