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Class 2 Device Recall Biograph mCTS 40, |
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Date Initiated by Firm |
August 11, 2009 |
Date Posted |
November 10, 2009 |
Recall Status1 |
Terminated 3 on December 22, 2009 |
Recall Number |
Z-0163-2010 |
Recall Event ID |
53453 |
510(K)Number |
K060631
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Product Classification |
System, tomography, computed, emission - Product Code KPS
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Product |
Siemens Biograph mCT-S 40, model number 10248671.
Medical Imaging Equipment. |
Code Information |
serial number 1001 |
Recalling Firm/ Manufacturer |
Siemens Medical Solutions USA Inc. 810 Innovation Dr Knoxville TN 37932-2562
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For Additional Information Contact |
Maria Ebio 865-218-2532
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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.
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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 |
1 unit |
Distribution |
Worldwide Distribution -- United States (IL and OH), Germany, France and Hong Kong. |
Total Product Life Cycle |
TPLC Device Report
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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.
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510(K) Database |
510(K)s with Product Code = KPS and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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