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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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High RiskFDA Device
Medical Devices/Diagnostic Equipment

Siemens UROSKOP Omnia Systems Recalled for Fire Risk

Agency Publication Date: June 17, 2025
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Summary

Siemens Medical Solutions USA, Inc. is recalling approximately 120 UROSKOP Omnia and UROSKOP Omnia Max imaging systems. A component called a resistor in the frequency inverter can severely overheat, which may cause the plastic housing of the inverter to catch fire. No injuries or incidents have been reported to date, but the defect poses a significant fire hazard in clinical settings.

Risk

The frequency inverter's resistor can overheat to temperatures high enough to ignite its own plastic housing. This creates a risk of fire within the medical facility, which could lead to smoke inhalation or burn injuries for patients and healthcare providers.

What You Should Do

  1. This recall affects Siemens UROSKOP Omnia (Model 10094910) and UROSKOP Omnia Max (Model 10762473) imaging systems.
  2. To determine if your system is part of this recall, locate the model and serial number on the device identification label.
  3. See the Affected Products section below for the full list of affected codes.
  4. Stop using the recalled device immediately to prevent the risk of overheating and fire.
  5. Contact Siemens Medical Solutions USA, Inc. or your authorized distributor to arrange for a return, replacement, or technical correction.
  6. Call the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls for additional information regarding this safety notice.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: UROSKOP Omniaby Siemens
Model / REF:
10094910
Serial Numbers (95):
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
Product: UROSKOP Omnia Maxby Siemens
Model / REF:
10762473
Serial Numbers:
4014
4056
4049
4015
4063
4022
4036
4043
4024
4059
4020
4032
4053
4061
4060
4051
4025
4037
4054
4042
4033
4055
4052
4047
4062
UDI:
(01)04056869008981(21)4014
(01)04056869008981(21)4056
(01)04056869008981(21)4049
(01)04056869008981(21)4015
(01)04056869008981(21)4063
(01)04056869008981(21)4022
(01)04056869008981(21)4036
(01)04056869008981(21)4043
(01)04056869008981(21)4024
(01)04056869008981(21)4059
(01)04056869008981(21)4020
(01)04056869008981(21)4032
(01)04056869008981(21)4053
(01)04056869008981(21)4061
(01)04056869008981(21)4060
(01)04056869008981(21)4051
(01)04056869008981(21)4025
(01)04056869008981(21)4037
(01)04056869008981(21)4054
(01)04056869008981(21)4042
(01)04056869008981(21)4033
(01)04056869008981(21)4055
(01)04056869008981(21)4052
(01)04056869008981(21)4047
(01)04056869008981(21)4062

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97050
Status: Active
Manufacturer: Siemens Medical Solutions USA, Inc
Sold By: Siemens Medical Solutions USA, Inc
Manufactured In: United States
Units Affected: 2 products (95 units; 25 units)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.