Siemens Uroskop Omnia Max Fluoroscopic X-ray System Recall for Swivel Arm Defect
Siemens is recalling 191 Uroskop Omnia Max fluoroscopic X-ray systems because the swivel arm holding the monitors may become dislodged from the carrying arm.
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: The recall involves a risk-of-harm product (falling monitors) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 191 units of the Uroskop Omnia Max fluoroscopic X-ray system, Model # 10762473. The device is intended to visualize anatomical structures by converting an X-ray pattern into a visible image.
The recall is due to a defect where the swivel arm holding the monitors may become dislodged from the carrying arm. This issue could result in the monitors falling.
The affected units were distributed nationwide in the United States. Users should check their serial numbers against the list provided in the official recall notice to determine if their device is affected.
The recalled product
- Product
- Uroskop Omnia Max -fluoroscopic X-ray system Model # 10762473 Uroskop Omnia Max is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image.
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Hazard
- Affected units
- 191
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.
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