—#137253

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.

FDA product code: JAA — System, X-Ray, Fluoroscopic, Image-Intensified
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K101491
Affected lot / code info: 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

Why it was recalled

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 (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 51 Valley Stream Pkwy, Malvern, Pennsylvania 19355-1406

Distribution

Distribution pattern: Nationwide Distribution.

Timeline

Recall initiated: 2015-04-13
Posted by FDA: 2015-05-23
Terminated: 2017-03-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #137253. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.