The Recall Desk
HighFDA (Devices)·Z-0985-2019·Announced 2019-03-13

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.

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 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.
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.

See all 2 products in this recall →

Same manufacturer · Siemens Medical Solutions USA, Inc

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