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Class 2 Device Recall CIOS ALPHA |
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Date Initiated by Firm |
February 19, 2016 |
Date Posted |
March 31, 2016 |
Recall Status1 |
Terminated 3 on March 20, 2017 |
Recall Number |
Z-1278-2016 |
Recall Event ID |
73605 |
510(K)Number |
K132094
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Product Classification |
Interventional fluoroscopic x-ray system - Product Code OWB
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Product |
Cios Alpha, mobile X-ray system |
Code Information |
Model # 10308191 |
Recalling Firm/ Manufacturer |
Siemens Medical Solutions USA, Inc 40 Liberty Blvd Malvern PA 19355-1418
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For Additional Information Contact |
Anastasia Sokolova 610-448-6478
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Manufacturer Reason for Recall |
Software issues on Cios Alpha mobile C-Arm system
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FDA Determined Cause 2 |
Software in the Use Environment |
Action |
Siemens sent an Customer Safety Advisory Notice on February 26, 2016, to inform them of some issues that may arise on the Cios Alpha unit. The letter identified the product the problem and the action needed to be taken by the customer.
Users were instructed to change the date format to DDMMYYYY to prevent issues, not to release radiation as long as the DVD icon is blinking and to disconnect and re-connect the trolley if the system is needed immediately. In the meantime they are preparing a modification of Cios Alpha that will resolve the above-mentioned issues. As soon as the modification is available, a service engineer will get in touch with each customer and implement the modification to the Cios Alpha system free of charge. If the device was sold, customers were instructed to forward the recall notification to the new owner.
For further questions please call (610) 448-6478. |
Quantity in Commerce |
89 systems |
Distribution |
Nationwide Distribution to the states of : AL, AR, CA, CO, CT, DE, FL, GA, IA, IL, KY, MD, MI, MN, MO, NC, NE, NJ, NV, NY, OH, OR, PA, RI, SC, TN, TX, UT, WA and WI |
Total Product Life Cycle |
TPLC Device Report
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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.
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510(K) Database |
510(K)s with Product Code = OWB and Original Applicant = SIEMENS MEDICAL SOLUTIONS, INC.
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