Recall Z-2392-2023 ยท OWB Interventional Fluoroscopic X-Ray System
Canon Medical System, USA, INC.
INFX-8000C XGCP-930AA TABLE SIDE CONSOLE, INFX-8000C XGCP-930BA TABLE SIDE CONSOLE
| Date | Aug 11, 2023 (initiated Jun 22, 2023) |
| Status | Open, Classified |
| Reason | The C-arm, used to set the position and angle of the x-ray exposure field, may not function due to the tableside console PWB, which needs replacement. There may be a delay in the procedure, but procedures can continue using the operators console, the switches on the back of the column, switches on the side of the flat panel detector, and the emergency stop will continue to function normally. |
| Root cause | Nonconforming Material/Component |
| Action | On 6/22/23 correction notices were emailed to customers who were advised of the following: If the table side control does not function then the procedure can continue using the operators console in the operator room, the switches on the back of the column and the switches on the side of the flat panel detector. The emergency stop should not be affected and will continue to function normally. Neither manual operation or auto positioning of the C-arm can be performed on the console during procedure, and the C-arm will not operate. A firm representative will contact you to schedule a time to r |
| Quantity | 12 |
| Distribution | US Nationwide Distribution: NY, CO, IL, CA, MD, MN, WA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K210900 | Alphenix, INFX-8000C/B, INFX-8000C/S, V9.2 Canon Medical Systems Corporation, Apr 12, 2021 |