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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm May 27, 2004
Date Posted February 16, 2005
Recall Status1 Terminated 3 on October 07, 2008
Recall Number Z-0547-05
Recall Event ID 30802
510(K)Number K002715  K013504  K023518  K042467  K033431  
Product Classification System, Tomography, Computed, Emission - Product Code KPS
Product PET/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 
Recalling Firm/
Manufacturer		 CTI PET Systems Inc
810 Innovation Dr
Knoxville TN 37932-2562
For Additional Information Contact Richard 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
Action Written 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.
Distribution Nationwide, Germany, Spain, Italy, Korea and Canada
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = KPS and Original Applicant = CTI PET SYSTEMS, INC.
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