Recall Z-0108-2027 ยท OWB Interventional Fluoroscopic X-Ray System
Canon Medical System, USA, INC.
Alphenix INFX-8000C/B5
| Date | Oct 7, 2026 (initiated Aug 26, 2026) |
| Status | Open, Classified |
| Reason | Loosening of the bolts securing the longitudinal movement mechanism may cause the tabletop to shift, resulting in [positional/imaging/patient] misalignment and a longitudinal motion error |
| Root cause | Process control |
| Action | On August 26, 2026, Canon Medical Systems USA, Inc. issued a Urgent: Medical Device Correction notification to affected consignees via mail. Canon ask consignees to take the following actions: 1. Should this problem occur before inspection of the tightening of the bolt(s) is implemented on your system, please stop using the device and call your service representative. 2. Additionally, it is strongly requested that you share the contents of this letter with all users as well as clinical engineering or biomedical group at your facility. 3. A representative of Canon Medical Systems USA will c |
| Quantity | 1 unit |
| Distribution | US Nationwide distribution in the state of ID. |
| 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 |