Z-1981-2025Class II

UROSKOP Omnia. Model Number: 10094910

Name: Z-1981-2025 UROSKOP Omnia. Model Number: 10094910
Creator: Siemens Medical Solutions USA, Inc
Published: 2025-06-04
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2025-06-04 / Open, Classified / root cause: design

FDA source

Siemens Medical Solutions USA, Inc began a recall of UROSKOP Omnia. Model Number: 10094910 on 2025-06-04. FDA classified it as Class II and gives the reason as "A resistor in the frequency inverter may strongly overheat potentially igniting the plastic housing of the frequency inverter on fire". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1981-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-06-04
Posted: 2025-06-17
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: UROSKOP Omnia. Model Number: 10094910
Product code: JAA System, X-Ray, Fluoroscopic, Image-Intensified
Reason for recall: A resistor in the frequency inverter may strongly overheat potentially igniting the plastic housing of the frequency inverter on fire.
Root cause tag: design
FDA 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 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.
Quantity in commerce: 95 units
Distribution: Nationwide distribution.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1981-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1981-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-06-25	2025-06-17
Z-1982-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-06-25	2025-06-17

Product code JAA

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)