Recall Z-1982-2025 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
Siemens Medical Solutions USA, Inc
UROSKOP Omnia Max. Model Number: 10762473
| Date | Jun 17, 2025 (initiated Jun 4, 2025) |
| Status | Open, Classified |
| Reason | A resistor in the frequency inverter may strongly overheat potentially igniting the plastic housing of the frequency inverter on fire. |
| Root cause | Device Design |
| Action | Siemens notified consignees on about 06/04/2025 via letter. Consignees were instructed that they can continue to use their system when paying attention for signs of burning smell and/or smoke coming from the device base. In this case, the system must be immediately disconnected from power supply via room emergency on/off switch and the Siemens Healthineers Service Organization must be informed. Siemens Healthineers is preparing an on-site field safety corrective action to replace the frequency inverter by another type that cannot cause the described problem. The field safety corrective acti |
| Quantity | 25 units |
| Distribution | Nationwide distribution. |
| FDA record | Open on fda.gov |