Company:Siemens Medical Solutions USA, Inc
Date of Enforcement Report: 10/7/2014
Class lI:
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
Recall Number Z-0004-2015
REASON
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 have been sent to PACS or hardcopy/filming, thus leading to potentially incorrect diagnosis.
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Malvern, PA on 9/2/2014 Voluntary: Firm Initiated recall is ongoing
VOLUME OF PRODUCT IN COMMERCE
2
DISTRIBUTION
Nationwide
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