UROSKOP Omnia Medical Imaging Device Recalled for Fire Hazard
Siemens Medical Solutions is recalling 95 units of the UROSKOP Omnia medical imaging device nationwide due to a resistor in the frequency inverter that may overheat and ignite the plastic housing. No injuries have been reported.
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 involving a potential fire hazard from equipment failure, which could result in serious injury or property damage. However, no injuries or incidents have been reported, and the hazard is theoretical (the resistor may overheat). Per the severity rubric, risk-of-harm products without reported injury are scored at most 3.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 95 units of the UROSKOP Omnia medical imaging device, Model Number 10094910, distributed nationwide. A resistor in the frequency inverter may overheat and potentially ignite the plastic housing of the inverter, creating a fire hazard.
The affected units are identified by specific serial numbers. Healthcare facilities using these devices should verify their equipment against the provided serial number list and take appropriate action regarding affected units.
No injuries or incidents have been reported to date. Affected facilities should contact Siemens Medical Solutions USA, Inc. for guidance on corrective measures.
The recalled product
- Product
- UROSKOP Omnia. Model Number: 10094910
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Hazard
- fire
- burn-injury
- electrical-hazard
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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