Recall Z-1154-2024 ยท OWB Interventional Fluoroscopic X-Ray System
Canon Medical System, USA, INC.
The device is an X-ray system that is capable of radiographic and fluoroscopic studies and is used in an interventional setting. The system consists of a C-arm which is equipped with an X-ray tube, beam limiter and X-ray receptor, X-ray controller, computers with system and processing software, and a patient radiographic table.
| Date | Feb 16, 2024 (initiated Nov 15, 2023) |
| Status | Open, Classified |
| Reason | VAREX changed the manufacturing of the internal board, and the detectors displayed abnormal images. Internal board of the X-ray flat panel detector may display abnormal images, such as horizontal stripes, which may lead to the inability to complete an ongoing exam, or the patient may need to be examined with another x-ray system. |
| Root cause | Component change control |
| Action | On 11/15/23 correction notices were distributed to customers who were asked to do the following: 1) Should this issue occur please attempt to restart the system and contact your service representative. 2) A recalling firm representative will contact you to schedule a time to replace the flat panel detector on the console. The parts required to address the defect are expected to be available no earlier that December 2023. 3) Complete and return the customer reply form via email to RAFFAIRS@US.MEDICAL.CANON For questions, please contact our InTouch team at intouchdispatch@us.medical.canon or 8 |
| Quantity | 1 |
| Distribution | US: CA, LA |
| 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 |