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U.S. Department of Health and Human Services

Class 2 Device Recall

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 Class 2 Device Recallsee related information
Date Initiated by FirmMay 27, 2004
Date PostedFebruary 16, 2005
Recall Status1 Terminated 3 on October 07, 2008
Recall NumberZ-0547-05
Recall Event ID 30802
510(K)NumberK033431 K042467 K023518 K013504 K002715 
Product Classification System, Tomography, Computed, Emission - Product Code KPS
ProductPET/CT Software Versions MSV 1.0 and 1.1 used in the following PET (Positron Emission Tomography) and X-Ray Computed Tomography (CT) systems: Siemens Models: Biograph PET/CT CTI Models: Reveal PET/CT
Code Information 0054081001, 0054081002, 0054081003, 0054081004, 0054081006, 0054081007, 0054081008, 0054081009, 0054081010, 0054081011, 0054081012, 0054081013, 0054081014, 0054081015, 0054081016, 0054081017, 0054081018, 0054081020, 0054081021, 0054081022, 0054081023, 0054081024, 0054081025, 0067331002, 0067331003, 0067331004, 0067331005, 0067331006, 0067331007, 0067331008, 0067331009, 0067331010, 0067331011, 0067331012, 0067331013, 0067331014, 0067331015, 0067331016, 0067331017, 0067331018, 0067331019, 0067331020, 0067331021, 0067331022, 0067331023, 0067331024, 0067331025, 0067331026, 0067331027, 0067331029, 0067331030, 0067331031, 0067331032, 0067331033, 0067331034, 0067331035, 0067331036, 0067331037, 0067331038, 0067331039, 0067331040, 0067331041, 0067331042, 0067331043, 0067331044, 0067331045, 0067331046, 0067331047, 0067331048, 0067331049, 0067331050, 0067331051, 096-001002, 096-001004, 096-001005, 096-001006, 096-001007,  096-001008, 096-001009, 096-001011, 096-001012, 096-001013, 096-001014, 096-001015,  096-001016, 096-001017, 096-011002, 096-011003, 096-011005, 096-011006, 096-011007,  096-011008, 096-011009, 096-011010, 096-011011, 096-011012, 096-011013, 096-011014,  096-011015, 096-011016, 096-011017, 096-011018, 096-011019, 096-011020, 214-001002,  214-001003, 214-001004, 214-001005, 214-001006, 214-001007, 214-001008, 214-001016,  214-01001A, 214-011001, 214-011002, 214-011003, 214-011004, 214-011005, 214-011006,  214-011007, 214-011008, 214-011009, 214-011010, 214-011011, 214-011012, 214-011013,  214-011014, 214-011015, 214-011017, 214-011018, 214-011019, 214-011020, 214-011021,  214-011022, 214-011023, 214-011024, 214-011025, 214-011026, 214-011027, 214-011028,  214-011029, 214-011030, 214-011031, 214-011032, 214-011033, 214-011034, 214-011035,  214-011036, 214-011037, 214-011038, 214-011039, 214-011040, 214-011041, 214-011042,  216-001001, 216-001006, 216-001009, 216-001011, 216-001013, 216-001014, 216-001015,  216-001016, 216-001017, 216-001018, 216-001019, 216-001020, 216-001021, 216-001022,  216-001023, 216-001024, 216-001026, 216-001027, 0064871002, 0064871003, 0064871004, 0064871005, 0064871006, 0064871007, 0064871008, 0064871009, 0064871010, 0064871011, 0064871012, 0064871013, 0064871014, 0064871015, 0064871016, 0064871017, 0064871018, 0064871019, 0064871020, 0069391014, 0071301002, 0071301003, 0071301004, 0071301005, 0071301006, 0071301007, 0071301008, 0071301009, 0071301010, 0067331011, 0071301012, 0071301013, 0071301015, 0071301016, 0071301017, 0071301018, 0071301019, 0071301020, 0071301021, 0071301022, 0071301024 
FEI Number 1034973
Recalling Firm/
Manufacturer		 CTI PET Systems Inc
810 Innovation Dr
Knoxville TN 37932-2562
For Additional Information ContactRichard Powers
865-218-3019
Manufacturer Reason
for Recall		Misalignment of CT and PET scans from performing additional CT scans may produce an incorrect fused data set. In performing additional CT scans, the original PET and CT scans may become misaligned and produce an incorrect fused data set.
FDA Determined
Cause 2		Other
ActionWritten notification was sent via letter on May 27, 2004 to the end users to alert the consignees of the problem. The corrective software was mailed on December 17, 2004.
DistributionNationwide, Germany, Spain, Italy, Korea and Canada
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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