The Recall Desk
HighFDA (Devices)·Z-0984-2019·Announced 2019-03-13

Siemens Uroskop Omnia Fluoroscopic X-ray System Recalled for Monitor Arm Defect

Siemens is recalling six Uroskop Omnia 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 structural defect in a medical device that could result in falling equipment, representing a risk of harm where injury has not yet been reported.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling six units of the Uroskop Omnia fluoroscopic X-ray system, Model # 10094910. The affected units are identified by serial numbers 3414, 3415, 3416, 3417, 3418, and 3428. The Uroskop Omnia is a solid state detector fluoroscopic X-ray system primarily used for urological applications, including functional x-ray diagnosis, endourology, and minimal invasive urology/surgery.

The recall was initiated because the swivel arm holding the monitors may become dislodged from the carrying arm. This defect presents a risk of the monitors falling. The affected units were distributed nationwide in the United States.

Healthcare facilities and users of these specific serial numbers should stop using the affected equipment and contact Siemens Medical Solutions USA, Inc. for further instructions on repair or replacement.

The recalled product

Product
Uroskop Omnia -fluoroscopic X-ray system Model # 10094910 The Uroskop Omnia is 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
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 Numbers: 3414 3415 3416 3417 3418 3428

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 →

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