Recall Z-1666-2022 ยท OWB Interventional Fluoroscopic X-Ray System
Canon Medical System, USA, INC.
INFX-8000V. For radiographic and fluoroscopic studies and intervention.
| Date | Jan 31, 2022 |
| Status | Open, Classified |
| Reason | The fluoroscopic dose rate might exceed the conforming value during biplane fluoroscopy. |
| Root cause | Software design |
| Action | Canon sent an Urgent Electronic Product Radiation Warning letter dated July 28, 2022 to customers. . Customer were informed that in the interim a temporary countermeasure will be performed until such time as the software becomes available. A representative of Canon Medical Systems USA will contact you to schedule a time to install the countermeasure and at a later date, the updated software to address the issue. For scheduling questions, please contact our InTouch team at intouchdispatch@us.medical.canon. For questions call 800-421-1968 or your Canon service representative at 800.521.1968. |
| Quantity | 16 systems |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K170909 | Infinix INFX-8000V, V6.40 Toshiba Medical Systems Coroporation, Jun 16, 2017 |