FDA Medical Device Recalls (openFDA)
CTI PET Systems Inc: 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
- Recall number
- Z-0547-05
- Recalling firm
- CTI PET Systems Inc
- 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
- Status
- Terminated
- Initiated
- 2004-05-27
- Posted
- 2005-02-16
- Terminated
- 2008-10-07
- Reason
- 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.
- Root cause
- 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.
- Quantity
- not on file
- Distribution
- Nationwide, Germany, Spain, Italy, Korea and Canada
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K002715","K013504","K023518","K033431","K042467"]
- PMA numbers
- not on file
- Product code
- KPS
- Firm FEI
- 1034973
- Firm city
- Knoxville
- Firm state
- TN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28