Recall Z-3014-2026 ยท OWB Interventional Fluoroscopic X-Ray System
Canon Medical System, USA, INC.
Alphenix Models INFX-8000C INFX-8000F INFX-8000V This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration. The system is indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen and lower extremities.
| Date | Aug 25, 2026 (initiated Aug 4, 2026) |
| Status | Open, Classified |
| Reason | Due to the fixing screws of ceiling movement gear in ceiling suspended arm that are part of the X-ray interventional systems may become loose. |
| Root cause | Process control |
| Action | On 08/04/2026, an "URGENT: MEDICAL DEVICE CORRECTION" letter was sent via email informing customers that, It has been found there is a possibility that the fixing screws of ceiling movement gear in ceiling suspended arm that are part of the X-ray interventional systems may become loose. Indications that the screws have loosened are abnormal noises and sensor errors from the ceiling mounted C-arm. Customers are instructed to: Should the suspended device make an abnormal noise, or a sensor error is displayed before the corrective action is implemented on your system, please stop using the devic |
| Quantity | 10 systems |
| Distribution | U.S. Nationwide distribution in the states of CA, GA, MN, NC, NV, PA, OH, and TX. |
| FDA record | Open on fda.gov |