Recall Z-1155-2024 ยท OWB Interventional Fluoroscopic X-Ray System
Canon Medical System, USA, INC.
The INFX-8000F is designed to take advantage of the latest technological innovations to reduce dose and to save time. A revolutionary graphic user interface and a multi-tasking computer enable the system to fully meet the requirement for optimum image quality, safety, ease of use, advanced efficiency and improved workflow. The advanced floormounted system INFX-8000F uses a new flat panel detector
| 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 | 2 |
| Distribution | US: CA, LA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K182415 | Alphenix, INFX-8000F/B, V8.0 Canon Medical Systems Corporation, Sep 28, 2018 |