CLASS II Device recall · Reported 8 Oct 2014 · FDA Enforcement Report

Siemens Uroskop Omnia Max system The Uroskop Omnia is recalled

Siemens Medical Solutions USA is recalling Siemens Uroskop Omnia Max system The Uroskop Omnia is a solid state detector fluoroscopic, distributed nationwide in the US. The recall was initiated on 2 Sep 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSiemens Uroskop Omnia Max system, material #s: 10762473, serial numbers: 4014 4015

Quantity recalled2

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0004-2015
FDA event ID: 69258
Recalling firm: Siemens Medical Solutions USA, Malvern, PA
Classification: Class II
Status: Terminated
Recall initiated: 2 Sep 2014
FDA classified: 2 Oct 2014
Reported: 8 Oct 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Surgical Instruments

Timeline

2 Sep 2014	Recall initiated by company
2 Oct 2014	Classified by FDA	+30 days
8 Oct 2014	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Two malfunctions posing potential risk to patients were identified with Siemens Ysio Max, AXIOM Luminos dRF Max, Uroskop Omnia Max, and Luminos Agile Max systems with a specific set of serial numbers that will cause lost images due to an automatic Radiology Information System (RIS) worklist update, thus causing examinations to be repeated. Image label may also be displayed incorrectly after images

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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 treatment table, may be used for urological, gastroenterological and gynecological treatment, planning and diagnostic procedures including but not limited to: "Querying and retrieving patient history information and/or previous diagnosis and images from other modalities; "X-ray examinations of the urogenital area "Ultrasound examinations "Endourological interventions "Percutaneous interventions "Laparoscopy "Application of fistula "Simple procedures "Extracorporeal shock wave lithotripsy "Uroflow/urodynamics "Pediatric radiological and therapeutic applications

Where it was distributed

Nationwide Distribution - US including UT, MO, CO, MA, MN, MS, OH, SC, MI, and NY.

Nationwide Colorado Massachusetts Michigan Minnesota Missouri Mississippi New York Ohio South Carolina Utah

Questions about this recall

Is Siemens Uroskop Omnia Max system The Uroskop Omnia is a solid state detector fluoroscopic recalled?

Yes. Siemens Medical Solutions USA recalled Siemens Uroskop Omnia Max system The Uroskop Omnia is a solid state detector fluoroscopic on 2 Sep 2014. The recall is Class II and its status is Terminated. Recall number Z-0004-2015.

Why was it recalled?

Which lots are affected?

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

Where was it sold?

Nationwide Distribution - US including UT, MO, CO, MA, MN, MS, OH, SC, MI, and NY.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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