Z-0004-2015Class II

Siemens Uroskop Omnia Max system The Uroskop Omnia is a solid state detector fluoroscopic X-Ray system...

Name: Z-0004-2015 Siemens Uroskop Omnia Max system The Uroskop Omnia is a solid state detector fluoroscopic X-Ray system...
Creator: Siemens Medical Solutions USA, Inc
Published: 2014-09-02
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2014-09-02 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of Siemens Uroskop Omnia Max system The Uroskop Omnia is a solid state detector fluoroscopic X-Ray system, primarily for urological applications (functional x-ray... on 2014-09-02. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0004-2015
Classification: Class II
Status: Terminated
Initiated: 2014-09-02
Posted: 2014-10-02
Terminated: 2015-02-24
Recalling firm: Siemens Medical Solutions USA, Inc.
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 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
Product code: KPR System, X-Ray, Stationary
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
Root cause tag: software
FDA root cause: Software design
Action: Siemens sent a Safety Advisory Notice, dated September 2, 2014, to all affected customers. The Notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to disable the automatic RIS worklist update and perform this procedure manually. Customers should disable the Measurement Field Display and Collimator Display by setting the display time for both setting to 0 sec (if editable). Customers should forward the safety notice to the new owner and inform Siemens of the new owner where possible. Customers with questions should call 610-219-2119 or 610-219-4834. For questions regarding this recall call 610-219-6300.
Quantity in commerce: 2
Distribution: Nationwide Distribution - US including UT, MO, CO, MA, MN, MS, OH, SC, MI, and NY.
Product codes and lots: Siemens Uroskop Omnia Max system, material #s: 10762473, serial numbers: 4014 4015

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0004-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0002-2015	Class II	Terminated	Voluntary: Firm initiated	2014-10-08	2014-10-02
Z-0003-2015	Class II	Terminated	Voluntary: Firm initiated	2014-10-08	2014-10-02
Z-0004-2015	Class II	Terminated	Voluntary: Firm initiated	2014-10-08	2014-10-02
Z-0005-2015	Class II	Terminated	Voluntary: Firm initiated	2014-10-08	2014-10-02

Product code KPR

K101491Class IIUroskop OmniaSiemens Medical Solutions USA, Inc. / cleared 2010-06-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)