Z-1670-2015Class II

SIEMENS Uroskop Omnia Max ; a solid state detector fluoroscopic X-Ray system, primarily for urological...

Name: Z-1670-2015 SIEMENS Uroskop Omnia Max ; a solid state detector fluoroscopic X-Ray system, primarily for urological...
Creator: Siemens Medical Solutions USA, Inc
Published: 2015-04-13
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2015-04-13 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of SIEMENS Uroskop Omnia Max ; a solid state detector fluoroscopic X-Ray system, primarily for urological applications (functional x-ray diagnostic, endourology... on 2015-04-13. FDA classified it as Class II and gives the reason as "Study and all acquired images deleted when using systems with software version VE10E. Acquisitions have to be repeated. Connection with portable detectors (MAX wi-D, MAX mini) is sporadic in image recovery. Pressing...". 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-1670-2015
Classification: Class II
Status: Terminated
Initiated: 2015-04-13
Posted: 2015-05-23
Terminated: 2017-03-20
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: SIEMENS Uroskop Omnia Max ; 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, including 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: JAA System, X-Ray, Fluoroscopic, Image-Intensified
Reason for recall: Study and all acquired images deleted when using systems with software version VE10E. Acquisitions have to be repeated. Connection with portable detectors (MAX wi-D, MAX mini) is sporadic in image recovery. Pressing undo button on the RAD subtask card or previous series button on the Image subtask card during image readout. Sporadically, during an automatic or a manual RIS update.
Root cause tag: software
FDA root cause: Software design
Action: A safety advisory notice, dated April 13, 2015, was sent to end users with affected devices to alert them about the issue and associated risks,and to provide instructions for avoiding potential risk. A new software version will be released to permanently resolve the issue.
Quantity in commerce: 133 total
Distribution: Nationwide Distribution.
Product codes and lots: Model Number of device 10762473 with serial numbers: 4014 4056 4015 4063 4022 4036 4043 4024 4059 4020 4032 4053 4061 4060 4051 4025 4037 4054 4042 4033 4055 4052 4047 4049 4038 4062

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1670-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1667-2015	Class II	Terminated	Voluntary: Firm initiated	2015-06-03	2015-05-23
Z-1668-2015	Class II	Terminated	Voluntary: Firm initiated	2015-06-03	2015-05-23
Z-1669-2015	Class II	Terminated	Voluntary: Firm initiated	2015-06-03	2015-05-23
Z-1670-2015	Class II	Terminated	Voluntary: Firm initiated	2015-06-03	2015-05-23

Product code JAA

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)