Recall Z-0547-05 ยท KPS System, Tomography, Computed, Emission
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
| Date | Feb 16, 2005 (initiated May 27, 2004) |
| Status | Terminated |
| 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. |
| Distribution | Nationwide, Germany, Spain, Italy, Korea and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K002715 | ECAT PET SCANNER Cti Pet Systems, Inc., Oct 31, 2000 |
| K013504 | MODIFICATION TO: ECAT LSO PET/CT SCANNER Cti Pet Systems, Inc., Oct 31, 2001 |
| K023518 | ECAT LSO PET/CT 16 Cti Pet Systems, Inc., Nov 8, 2002 |
| K033431 | LSO PET/CT HIREZ AND LSO PET/CT 16 HIREZ Cti Pet Systems, Inc., Nov 20, 2003 |
| K042467 | LSO PET/CT HIREZ 64 Cti Pet Systems, Inc., Oct 1, 2004 |