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U.S. Department of Health and Human Services

Class 2 Device Recall Cios Alpha

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  Class 2 Device Recall Cios Alpha see related information
Date Initiated by Firm May 05, 2015
Date Posted July 02, 2015
Recall Status1 Terminated 3 on January 13, 2017
Recall Number Z-1958-2015
Recall Event ID 71270
510(K)Number K132094  
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
Product Cios Alpha; The Cios Alpha is a mobile X-ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications. Clinical applications may include but are not limited to: interventional fluoroscopic, gastro-intestinal, endoscopic, urologic, pain management, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The patient population may include pediatric patients
Code Information Model Number of device 10308191, serial numbers: 11032 11044 11005 10115 11056 10057 10076 10019 10021 10035 10037 10073 11074 11075 11077 11083 10078 11066 11067 11013 10063 10082 11094 10089 11080 11009 11018 11082 10058 10098 11015 11016 11038 10096 10116 11035 11064 
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		 under certain circumstances the Cios Alpha system may freeze during a procedure.
FDA Determined
Cause 2		 Software design
Action Siemens sent an Safety Advisory Notice dated May 5 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. They were alerting them about the issue and risks involved. Customers were provided work-around instructions until a software fix is released. For further questions please call (610) 219-6300.
Quantity in Commerce 37
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 = OWB and Original Applicant = SIEMENS MEDICAL SOLUTIONS, INC.
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