Recall Z-0290-2027 ยท OWB Interventional Fluoroscopic X-Ray System
Canon Medical System, USA, INC.
ALPHENIX INTERVENTIONAL ANGIOGRAPHY SYSTEM REF: INFX-8000F
| Date | Oct 27, 2026 (initiated Oct 12, 2026) |
| Status | Open, Classified |
| Reason | Due to software issue, X-ray interventional system may experience internal error if F-Store or imagine acquisition is performed while clinical analysis function is use. |
| Root cause | Software design |
| Action | On October 12, 2026, Canon Medical Systems USA, Inc. issued a Urgent: Medical Device Correction to affected consignees. Canon provided the following to consignees: 1. A representative of Canon Medical Systems USA will contact you to schedule a time to conduct installation of modified software to prevent internal errors from occuring if F-STORE or image acquisition is performed while CAAS clinical analysis function is used. 2. If you have any questions regarding this matter, please contact your service representative or contact our InTouch team at (800) 521-1968 or by email intouchdispatch@us. |
| Quantity | 3 units |
| Distribution | US Nationwide distribution in the states of AL, AR, AZ, CA, FL, GA, HI, IL, LA, MA, MI, MN, MS, NC, NV, OH, OR, TX. |
| 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 |