Recall Z-1176-2021 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Canon Medical System, USA, INC.
System INFX-8000F
| Date | Feb 5, 2021 |
| Status | Open, Classified |
| Reason | The x-ray irradiation field may shift with respect to image receiving surface displayed on the screen at some C-arm angles. |
| Root cause | Software design |
| Action | A customer notification letter was sent to affected customers, which includes instructions to (1) manually operate the diaphragm blades of the collimator to adjust the X-ray irradiation field to the appropriate irradiation field position, (2) when adjusting the diaphragm blades, you can find this problem by checking the position of the diaphragm blades with respect to the image receiving surface displayed on the screen, (3) contact their Canon Service representative if they find any abnormalities regarding this issue in the operation of the Infinix System and if they have any questions. And in |
| Quantity | 272 in total |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081624 | INFX-8000F (INFINIX CSI AND INFINIX DPI) Toshiba America Medical Systems, In.C, Jun 23, 2008 |