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.
What this means for you
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
- Hazard
- fire
- overheating
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.
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