INFX-8000C XGCP-930AA TABLE SIDE CONSOLE, INFX-8000C XGCP-930BA TABLE SIDE CONSOLE
FDA device recall Z-2392-2023 · posted 2023-08-11 · Open, Classified
Recall details
- Recalling firm
- Canon Medical System, USA, INC.
- Reason for recall
- 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.
- Action taken
- 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 replace the PWB on the console. Complete and return the customer reply form to RAffairs@us.medical.canon For questions, contact the InTouch team at intouchdispatch@us.medical.canon or your service representative at 800.521.1968
- Root cause
- Nonconforming Material/Component
- Status
- Open, Classified
- Product code
- OWB
- Quantity affected
- 12
- Distribution
- US Nationwide Distribution: NY, CO, IL, CA, MD, MN, WA
- Date initiated
- 2023-06-22
- Date posted
- 2023-08-11
- Location
- Tustin, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Alphenix, INFX-8000C/B, INFX-8000C/S, V9.2 (K210900) | Canon Medical Systems Corporation | 2021-04-12 |