UROSKOP Omnia (Siemens Medical) – Frequency Inverter Fire Risk (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
UROSKOP Omnia. Model Number: 10094910
Brand
Siemens Medical Solutions USA, Inc
Lot Codes / Batch Numbers
Model Number: 10094910. No UDI. Serial Numbers: 3054, 3029, 3062, 3169, 3402, 3103, 3053, 3055, 3072, 3019, 3048, 3403, 3058, 1045, 2014, 3091, 3013, 3023, 3115, 3051, 3417, 3160, 2033, 3163, 3052, 3166, 3099, 3138, 3157, 3038, 3131, 3037, 3117, 3118, 3096, 3123, 3124, 2022, 2032, 2031, 3134, 3106, 3415, 3042, 3014, 3012, 3108, 3105, 3057, 2008, 3122, 3034, 3151, 3414, 2030, 3021, 3119, 3086, 3073, 3089, 3036, 3031, 3409, 3064, 3153, 3095, 3145, 3079, 3017, 3025, 3076, 2046, 2047, 2055, 2054, 2049, 3416, 2015, 1041, 3155, 3418, 3081, 3084, 2045, 3015, 3125, 3132, 3143, 3085, 3405, 2041, 2009, 3410, 2029, 3404.
Products Sold
Model Number: 10094910. No UDI. Serial Numbers: 3054, 3029, 3062, 3169, 3402, 3103, 3053, 3055, 3072, 3019, 3048, 3403, 3058, 1045, 2014, 3091, 3013, 3023, 3115, 3051, 3417, 3160, 2033, 3163, 3052, 3166, 3099, 3138, 3157, 3038, 3131, 3037, 3117, 3118, 3096, 3123, 3124, 2022, 2032, 2031, 3134, 3106, 3415, 3042, 3014, 3012, 3108, 3105, 3057, 2008, 3122, 3034, 3151, 3414, 2030, 3021, 3119, 3086, 3073, 3089, 3036, 3031, 3409, 3064, 3153, 3095, 3145, 3079, 3017, 3025, 3076, 2046, 2047, 2055, 2054, 2049, 3416, 2015, 1041, 3155, 3418, 3081, 3084, 2045, 3015, 3125, 3132, 3143, 3085, 3405, 2041, 2009, 3410, 2029, 3404.
Siemens Medical Solutions USA, Inc is recalling UROSKOP Omnia. Model Number: 10094910 due to A resistor in the frequency inverter may strongly overheat potentially igniting the plastic housing of the frequency inverter on fire.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
A resistor in the frequency inverter may strongly overheat potentially igniting the plastic housing of the frequency inverter on fire.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026