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U.S. Department of Health and Human Services

Class 2 Device Recall Biograph mCTS 64

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 Class 2 Recall
Biograph mCTS 64
see related information
Date Posted November 10, 2009
Recall Status1 Terminated on December 22, 2009
Recall Number Z-0164-2010
Recall Event ID 53453
Premarket Notification
510(K) Number
K081453 
Product Classification System, Tomography, Computed, Emission - Product Code KPS
Product Siemens Biograph mCT-S 64, model number 10248672. Medical Imaging Equipment.
Code Information serial numbers: 1002 and 1003
Recalling Firm/
Manufacturer
Siemens Medical Solutions USA Inc.
810 Innovation Dr
Knoxville, Tennessee 37932-2562
For Additional Information Contact Maria Ebio
865-218-2532
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
DESIGN: 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 2 units
Distribution Worldwide Distribution -- United States (IL and OH), Germany, France and Hong Kong.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = KPS and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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