| Class 2 Device Recall SIEMENS Uroskop Omnia Max |  |
Date Initiated by Firm | April 13, 2015 |
Date Posted | May 23, 2015 |
Recall Status1 |
Terminated 3 on March 20, 2017 |
Recall Number | Z-1670-2015 |
Recall Event ID |
71115 |
510(K)Number | K101491 |
Product Classification |
System, x-ray, fluoroscopic, image-intensified - Product Code JAA
|
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. |
Code Information |
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 |
Recalling Firm/ Manufacturer |
Siemens Medical Solutions USA, Inc 51 Valley Stream Pkwy Malvern PA 19355-1406
|
For Additional Information Contact | Customer Support 610-219-6300 |
Manufacturer 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. |
FDA Determined Cause 2 | 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. |
Total Product Life Cycle | TPLC Device Report |
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database | 510(K)s with Product Code = JAA
|
|
|
|