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U.S. Department of Health and Human Services

Class 2 Device Recall Biograph mCtX

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  Class 2 Device Recall Biograph mCtX see related information
Date Initiated by Firm August 11, 2009
Date Posting Updated November 10, 2009
Recall Status1 Terminated 3 on December 22, 2009
Recall Number Z-0162-2010
Recall Event ID 53453
510(K)Number K060631  
Product Classification System, tomography, computed, emission - Product Code KPS
Product Siemens Biograph mCt-X, model number 10248670.

Medical Imaging Equipment.
Code Information serial numbers: 1001, 1002 and 1003
Recalling Firm/
Siemens Medical Solutions USA Inc.
810 Innovation Dr
Knoxville TN 37932-2562
For Additional Information Contact Maria Ebio
Manufacturer Reason
for Recall
In the unlikely event that the device is modified to operate in the tilted position, the telescoping support mechanism will not engage properly.
FDA Determined
Cause 2
Device Design
Action Siemens Medical Solutions USA, Inc. issued an "Urgent Field Correction - Recall" notice to consignees by letter dated September 3, 2009 informing them of the problem and that a Siemens service representative will be in contact shortly to service the affected product. For further information, contact Siemens at 1-800-888-7436.
Quantity in Commerce 3 units
Distribution Worldwide Distribution -- United States (IL and OH), Germany, France and Hong Kong.
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.