| Class 2 Device Recall Siemens Ysio Max system | |
Date Initiated by Firm | September 02, 2014 |
Date Posted | October 02, 2014 |
Recall Status1 |
Terminated 3 on February 24, 2015 |
Recall Number | Z-0002-2015 |
Recall Event ID |
69258 |
510(K)Number | K133259 |
Product Classification |
System, x-ray, stationary - Product Code KPR
|
Product | Siemens Ysio Max system
The Ysio Max is a radiographic system used in hospitals, clinics, and medical practices. Ysio Max enables radiographic and tomographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. It can also be used for intravenous, small interventions (like biopsy, punctures, etc.) and emergency (trauma, critical ill) applications. Exposures may be taken with the patient sitting, standing, or in the prone position. The Ysio Max system is not meant for mammography. The Ysio Max uses integrated or portable digital detectors for generating diagnostic images by converting x-rays into electronic signals. Ysio Max is also designed to be used with conventional film/screen or Computed Radiography (CR) cassettes. |
Code Information |
Siemens Ysio Max material #s: 10762470, serial numbers: 24033 24028 24024 24034 24015 24026 24014 24016 24025 24037 |
Recalling Firm/ Manufacturer |
Siemens Medical Solutions USA, Inc 51 Valley Stream Pkwy Malvern PA 19355
|
For Additional Information Contact | Customer Support 610-219-6300 |
Manufacturer 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 |
FDA Determined Cause 2 | 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 | 10 |
Distribution | Nationwide Distribution - US including UT, MO, CO, MA, MN, MS, OH, SC, MI, and NY. |
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 = KPR
|
|
|
|