Recall Z-0492-2022 ยท OWB Interventional Fluoroscopic X-Ray System
Canon Medical System, USA, INC.
Flat Panel Detector, Model Number: TFP-800A, used with the Alphenix Systems, Item Numbers: INFX-8000V, INFX-8000C, INFX-8000F, and INFX-8000H.
| Date | Dec 20, 2021 |
| Status | Open, Classified |
| Reason | Abnormal images such as horizontal stripes may be displayed and recovery may not not be possible by restarting the system. The worst case scenario is an operator who is working without a workable image may remove a catheter from the patient's blood vessel and damage the blood vessel. |
| Root cause | Vendor change control |
| Action | On 12/21/2021, the firm notified affected customers via a letter titled, "URGENT: MEDICAL DEVICE CORRECTION." The letter indicated, "Corrective Action: When the new parts become available, your Canon service representative will contact you for an appointment to schedule the installation of the modified x-ray flat panel detector and will install on your system. Requests to Customers: Should this problem occur before the modified x-ray flat panel detector is installed on your system, please attempt computer reboot, and contact your Canon service representative. If you have any questions regar |
| Quantity | 8 |
| Distribution | US Nationwide distribution in the states of DE, FL, LA, MT, NJ, OH, and WV. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K181670 | Alphenix, INFX-8000V/B, V8.0 Canon Medical Systems Corporation, Jul 25, 2018 |
| K181804 | Alphenix, INFX-8000C/B, V8.0 Canon Medical Systems Corporation, Aug 2, 2018 |
| K182415 | Alphenix, INFX-8000F/B, V8.0 Canon Medical Systems Corporation, Sep 28, 2018 |
| K182546 | Alphenix, INFX-8000H/B, V8.0 Canon Medical Systems Corporation, Oct 17, 2018 |