Z-0547-05

PET/CT Software Versions MSV 1.0 and 1.1 used in the following PET (Positron Emission Tomography) and X-Ray...

Name: Z-0547-05 PET/CT Software Versions MSV 1.0 and 1.1 used in the following PET (Positron Emission Tomography) and X-Ray...
Creator: CTI PET Systems Inc
Published: 2004-05-27
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2004-05-27 / Terminated

FDA source

CTI PET Systems Inc began a recall of 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... on 2004-05-27. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0547-05
Status: Terminated
Initiated: 2004-05-27
Posted: 2005-02-16
Terminated: 2008-10-07
Recalling firm: Siemens Medical Solutions USA, 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
Product code: KPS System, Tomography, Computed, Emission
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 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.
Distribution: Nationwide, Germany, Spain, Italy, Korea and Canada
Product codes and lots: 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

Product code KPS

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About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)