UROSKOP Omnia. Model Number: 10094910 recallZ-1981-2025 · Siemens Medical Solutions USA, Inc · initiated Jun 4, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Siemens Medical Solutions USA, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
A resistor in the frequency inverter may strongly overheat potentially igniting the plastic housing of the frequency inverter on fire.
FDA root cause category: Device Design
What the company is doing
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.
Recall details
- Recall number
- Z-1981-2025
- Status
- Open, Classified
- Initiated by the company
- Jun 4, 2025
- Posted by the FDA
- Jun 17, 2025
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 95 units
- Product code
- JAA
- FDA submissions
- K101491, K173639
- Distribution
- Nationwide distribution.
Product description
UROSKOP Omnia. Model Number: 10094910
Code information (models, lots, serial 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.
Other devices under the same FDA submission
2 devices cleared under K101491, K173639 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- LUMINOS Lotus Max 11574100Siemens Healthcare GmbH · Interventional fluoroscopic x-ray system2 recalls7 reports
- Multitom Rax 10860700Siemens Healthcare GmbH · Interventional fluoroscopic x-ray system3 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 97050).
- Z-1982-2025 · Open, ClassifiedUROSKOP Omnia Max. Model Number: 10762473
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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