UROSKOP Omnia. Model Number: 10094910
FDA Recall Z-1981-2025 · Posted 2025-06-17
Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusOpen, Classified
Product CodeJAA
Date Initiated2025-06-04
Product Quantity95 units
Reason for Recall
A resistor in the frequency inverter may strongly overheat potentially igniting the plastic housing of the frequency inverter on fire.
Firm 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 action will be implemented in the second quarter of 2025 with update XP008/25/S and will be provided to you free of charge.
Consignees were instructed to ensure that all affected personnel are informed as well as any customers if the unit was further distributed and to acknowledge receipt of the recall notification.
Root Cause
Device Design
Distribution Pattern
Nationwide distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.