Siemens Uroskop Omnia Max X-ray System Recalled for Support Arm Risk
Siemens is recalling 281 Uroskop Omnia Max X-ray systems because the monitor support arm may become dislodged after intense, long-term use.
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: The recall involves a risk-of-harm product (falling equipment) where injury has not yet been reported, which aligns with the High severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 281 units of the Uroskop Omnia Max, Model no. 10762473, a solid-state detector fluoroscopic X-ray system used primarily for urological applications. The recall is due to a residual risk that the monitor support arm may become dislodged if the arm is used intensely over a long period of time.
This issue is a residual risk that remained after a corrective action was performed on the monitor support arm in March 2019. The affected units were distributed worldwide. The recall covers specific serial numbers listed in the official FDA record.
Healthcare facilities should check their inventory for the affected serial numbers. If a unit is affected, Siemens will provide instructions for the necessary corrective actions to mitigate the risk of the support arm becoming dislodged.
The recalled product
- Product
- Uroskop Omnia Max, Model no. 10762473 - Product Usage: a solid state detector fluoroscopic X-ray system, primarily for urological applications (functional x-ray diagnosis, endourology and minimal invasive urology/surgery).
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Hazard
- Affected units
- 281
Distribution
Distribution scope not specified by the agency.
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.
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