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U.S. Department of Health and Human Services

Class 2 Device Recall Biograph mCT family

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  Class 2 Device Recall Biograph mCT family see related information
Date Initiated by Firm April 25, 2016
Date Posted June 15, 2016
Recall Status1 Terminated 3 on February 01, 2017
Recall Number Z-1999-2016
Recall Event ID 74239
510(K)Number K123737  
Product Classification System, tomography, computed, emission - Product Code KPS
Product BIOGRAPH mCT S(20) - 3R, MATERIAL NUMBER 10528956

Product Usage:
The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
Code Information Serial Number 11009
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA Inc.
810 Innovation Dr
Knoxville TN 37932-2562
For Additional Information Contact see comments
865-218-2000
Manufacturer Reason
for Recall		 The bracket that is used to lift the cover has bolts that were not welded in potentially causing the cover to fall down during service.
FDA Determined
Cause 2		 Process design
Action Siemens sent a Customer Safety Advisory Letter to all affected customers. The letter identified the affected product, problem and actions to be taken. Siemens service organization will be contacting customers to schedule the update as per the attached Update Instruction and will be provided the replacement bracket to resolve the issue. For questions contact your Siemens representative.
Quantity in Commerce 1 unit
Distribution Worldwide Distribution - US Nationwide and the countries of China and Malaysia.
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 = KPS and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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