Agency classClass IIOur severity:High FDA (Devices)·Z-0805-2021·Announced 2021-01-20

Siemens Uroskop Omnia X-ray System Recalled for Support Arm Risk

Siemens is recalling six Uroskop Omnia X-ray systems because the monitor support arm may become dislodged after intense, long-term use.

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 structural defect in a medical device that poses a risk of harm (dislodged arm) but does not report any injuries or fatalities, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling six units of the Uroskop Omnia, Model no. 10094910, a solid-state detector fluoroscopic X-ray system used primarily for urological applications. The affected units have serial numbers 3417, 3414, 3415, 3418, 3428, and 3416. These devices were distributed worldwide.

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 risk remains despite a corrective action performed on the monitor support arm in March 2019.

Healthcare facilities and users of these specific serial numbers should contact Siemens Medical Solutions USA, Inc. for instructions on how to address the potential defect.

The recalled product

Product: Uroskop Omnia, Model no. 10094910 - 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
Category: Medical Device — Imaging Equipment
Hazard: structural-defect
Affected units: 6

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 (1)

Serial Nos. 3417 3414 3415 3418 3428 3416

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.

See all 2 products in this recall →

Same manufacturer · Siemens Medical Solutions USA, Inc

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