The Recall Desk
HighFDA (Devices)·Z-0004-2015·Announced 2014-10-08

Siemens Uroskop Omnia Max X-Ray System Recalled for Image Loss

Siemens is recalling two Uroskop Omnia Max systems because a malfunction causes image loss and incorrect labels, leading to repeated examinations.

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 (medical device) where the malfunction leads to repeated examinations and potential diagnostic errors, but no specific injuries or illnesses have been reported in the source text.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling two Siemens Uroskop Omnia Max systems. These are solid-state detector fluoroscopic X-ray systems primarily used for urological applications, including functional x-ray diagnostics and minimal invasive surgery.

The recall is due to two malfunctions that pose a potential risk to patients. The issues cause the loss of images due to an automatic Radiology Information System (RIS) worklist update, which results in examinations being repeated. Additionally, image labels may be displayed incorrectly after the images are acquired.

The affected units are distributed nationwide in the US, including in Utah, Missouri, Colorado, Massachusetts, Minnesota, Mississippi, Ohio, South Carolina, Michigan, and New York. The specific serial numbers for the recalled units are 4014 and 4015. Users should contact Siemens Medical Solutions USA, Inc. for further instructions on how to address these malfunctions.

The recalled product

Product
Siemens Uroskop Omnia Max system The Uroskop Omnia is a solid state detector fluoroscopic X-Ray system, primarily for urological applications (functional x-ray diagnostic, endourology and minimal invasive urology/surgery). The system,, which includes a radiologic/urologic treat
Manufacturer
Siemens Medical Solutions USA, Inc
Category
Medical Device — Imaging Equipment
Hazard
Affected units
2

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 (3)

  • Siemens Uroskop Omnia Max system
  • material #s: 10762473
  • serial numbers: 4014 4015

Distribution

Distributed nationwide across the United States.

The notice also names 10 states specifically:

Part of a larger recall action

This product is one of 4 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 4 products in this recall →

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