Recall Z-1356-2023 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
Philips North America Llc
ProxiDiagnost R90 1.0 and 1.1 multi-functional general R/F system, Model Numbers 706100 and 706110
| Date | Apr 10, 2023 (initiated Oct 21, 2021) |
| Status | Open, Classified |
| Reason | If the system experiences an overvoltage / power surge it can cause a short circuit condition within the Main- cabinet. If this issue occurs, the user may experience an electrical fire within the cabinet, see or smell smoke emitting from the cabinet, or hear a popping sound coming from the cabinet. |
| Root cause | Device Design |
| Action | An IMPORTANT PRODUCT NOTICE dated 10/21/21 was sent to customers with the CombiDiagnost R90 system. The system may experience a short circuit of the Electromagnetic Interference (EMI) filter or UA/UB board, with a potential for smoke and/or a popping sound coming from the Main cabinet. If a user sees or smells smoke or hears a popping noise coming from the M-cabinet, immediately remove power to the room (main circuit breaker) and remove the patient. Stop using the system for further examinations. An IMPORTANT PRODUCT NOTICE dated 10/21/21 was sent to customers with the ProxiDiagnost N90. |
| Quantity | 243 units |
| Distribution | US Nationwide. Global Distribution. |
| FDA record | Open on fda.gov |