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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 August 17, 2015
Create Date October 23, 2015
Recall Status1 Terminated 3 on December 05, 2016
Recall Number Z-0118-2016
Recall Event ID 72138
510(K)Number K132094  
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
Product CIOS ALPHA; image intensified fluoroscopic x-ray system
Code Information model #10308191 with serial numbers: Serial 11032 10073 11132 11044 11005 10115 11056 10057 10076 10019 10035 11074 11075 11077 11083 11124 10078 11119 11103 11105 11013 10021 10037 10063 11106 10082 11098 11094 10089 11080 11009 11018 11082 10058 10098 11120 11134 11015 11016 11038 10116 11035 11107 11064 
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern PA 19355-1418
For Additional Information Contact Customer Support
610-219-6300
Manufacturer Reason
for Recall		 patient procedure interruption due to a potential system failure
FDA Determined
Cause 2		 Device Design
Action Customer Safety Advisory Notice XP038/15/S, dated August 17, 2015, was sent to direct accounts to alert them to the issue and provide work-around instructions to avoid potential risks.
Quantity in Commerce 44
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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