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U.S. Department of Health and Human Services

Class 2 Device Recall Biograph 40 TruePoint

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 Class 2 Recall
Biograph 40 TruePoint
see related information
Date Posted January 04, 2008
Recall Status1 Terminated on September 11, 2009
Recall Number Z-0248-2008
Recall Event ID 45153
Premarket Notification
510(K) Numbers
K002584  K003541  K940478  K962797 
Product Classification System, Tomography, Computed, Emission - Product Code KPS
Product Biograph 40 TruePoint, Biograph PET/CT Scanner, Catalog No. 10097303, Manufactured by Siemens Medical Solutions USA, Inc., 810 Innovation Drive, Knoxville, TN 37932 USA, TEL: 865-218-2534
Code Information Serial Numbers: 1001, 1002, and 1003
Recalling Firm/
Manufacturer
Siemens Medical Solutions USA Inc
810 Innovation Dr
Knoxville, Tennessee 37932-2562
For Additional Information Contact Maria Ebio
865-218-2534
Manufacturer Reason
for Recall
Visual asymmetric appearance; An asymmetry can be introduced into the attenuation-corrected PET images when using iterative reconstruction in combination with a specific number of subsets and reconstruction matrix sizes. (This problem only occurs when using protocols other than the default Biograph protocols)
FDA Determined
Cause 2
DESIGN: Software Design
Action A certified letter-Urgent Device Correction- dated June 15, 2007 was sent to all affected consignees on July 23, 2007 informing them of the problem (PET iterative reconstruction algorithm) and requesting as a short term fix that they discontinue the practice of operating using protocols other than the default Biograph. Software upgrades as the long term fix were promised in the Urgent Device Correction Notice. Updated information received October 4, 2007: a software patch to fix PETsyngo 5.0 was released, software patch to fix PETsyngo 4.x was released, and target date for the software patch to fix PETsyngo 3.2 and 3.4 is the end of November 2007.
Quantity in Commerce 3 units
Distribution Worldwide-USA and countries of Argentina, Austria, Australia, Belgium, Brazil, Canada, Switzerland, Chile, China, Czech Republic, Germany, Denmark, Spain, France, Great Britain, Hong Kong, Hungary, Ireland, India, Italy, Japan, South Korea, Kuwait, Lebanon, Mexico, Malaysia, Netherlands, Norway, Poland, Portugal, Sweden, Singapore, Slovak Republic, Thailand, Turkey, and Taiwan.
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 = CAO GROUP, INC.
510(K)s with Product Code = KPS and Original Applicant = CTI PET SYSTEMS, INC.
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