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U.S. Department of Health and Human Services

Class 2 Device Recall Biograph PET/CT, dist by Siemens Medical Solutions & Reveal PET/CT, dist CTI Molecular

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 Class 2 Device Recall Biograph PET/CT, dist by Siemens Medical Solutions & Reveal PET/CT, dist CTI Molecularsee related information
Date Initiated by FirmOctober 02, 2003
Date PostedNovember 13, 2003
Recall Status1 Terminated 3 on February 07, 2006
Recall NumberZ-0106-04
Recall Event ID 27358
510(K)NumberK013504 K002715 
Product Classification System, Tomography, Computed, Emission - Product Code KPS
ProductSiemens Models: BIOGRAPH, BIOGRAPH LSO and CTI Models: REVEAL HD, REVEAL RT
Code Information All CPS manufactured PET/CT systems distributed between October 31, 2000 and June 24, 2003.
FEI Number 1034973
Recalling Firm/
Manufacturer		 Cti Pet Systems Inc
810 Innovation Drive
Knoxville TN 37932-2571
For Additional Information ContactBrad Herrington
865-218-2361
Manufacturer Reason
for Recall		CPS has found that in some instances, when the CT E-Stop is activated, a malfunction may occur where the PHS controller may not shut down and stop bed motion.
FDA Determined
Cause 2		Other
ActionWritten notification was sent out beginning 10/02/2003 to distributors and end users to advise them of the problem.
Quantity in Commerce73
DistributionNationwide International: Japan, Germany, Brazil, Spain, China, Russia, Austrailia, Hong Kong, Singapore, Poland France, Korea, Greece, UK and Austria
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = KPS
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