PET/CT Software Versions MSV 1.0 and 1.1 used in the following PET (Positron Emission Tomography) and X-Ray Computed Tom
FDA device recall Z-0547-05 · posted 2005-02-16 · Terminated
Recall details
- Recalling firm
- CTI PET Systems Inc
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- KPS
- Distribution
- Nationwide, Germany, Spain, Italy, Korea and Canada
- Date initiated
- 2004-05-27
- Date posted
- 2005-02-16
- Date terminated
- 2008-10-07
- Location
- Knoxville, TN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LSO PET/CT HIREZ 64 (K042467) | Cti Pet Systems, Inc. | 2004-10-01 |
| LSO PET/CT HIREZ AND LSO PET/CT 16 HIREZ (K033431) | Cti Pet Systems, Inc. | 2003-11-20 |
| ECAT LSO PET/CT 16 (K023518) | Cti Pet Systems, Inc. | 2002-11-08 |
| MODIFICATION TO: ECAT LSO PET/CT SCANNER (K013504) | Cti Pet Systems, Inc. | 2001-10-31 |
| ECAT PET SCANNER (K002715) | Cti Pet Systems, Inc. | 2000-10-31 |