Agency classClass IIOur severity:High FDA (Devices)·Z-1981-2025·Announced 2025-06-25

UROSKOP Omnia X-ray System Model 10094910 Frequency Inverter Overheating Recall

Siemens is recalling 95 units of the UROSKOP Omnia X-ray system nationwide due to a resistor in the frequency inverter that may overheat and potentially ignite the plastic housing.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall for a medical device with a risk-of-harm defect (fire ignition). Although no reported illnesses or injuries are mentioned in the source text, the potential for fire in a medical environment constitutes a high-severity risk that meets the rubric criterion for High severity.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling the UROSKOP Omnia X-ray system, Model Number 10094910. The recall affects 95 units distributed nationwide.

A resistor in the frequency inverter may strongly overheat, potentially igniting the plastic housing of the frequency inverter. This fire hazard poses a risk to patients and medical facility personnel in the vicinity of the equipment.

Affected users should stop using devices with the serial numbers listed in this recall (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) and contact Siemens Medical Solutions USA, Inc. for remediation instructions.

The recalled product

Product: UROSKOP Omnia. Model Number: 10094910
Manufacturer: Siemens Medical Solutions USA, Inc
Category: Medical Device — Diagnostic Imaging / X-ray
Hazard: fire
overheating
Affected units: 95

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

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

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Siemens Medical Solutions USA, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Siemens Medical Solutions USA, Inc

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