ECAT Software Versions V7.1.1b, V7.2, V7.2.1, and V7.2.2 used in the following PET (Positron Emission Tomography) system
FDA device recall Z-0674-03 · posted 2003-03-21 · Terminated
Recall details
- Recalling firm
- Cti Pet Systems Inc
- Reason for recall
- Incorrect patient information is displayed in the reconstructed images of a whole body patient scan.
- Action taken
- Written notification was sent via letter with corrective software beginning on March 4 to the end users.
- Root cause
- Other
- Status
- Terminated
- Product code
- KPS
- Quantity affected
- 444
- Distribution
- Nationwide and the following foreign countries: Portugal, Japan Italy, belium, Taiwan, UK, Germany Canada Switzerland Netherlands, Austria, France, Turkey, Spain, Sweden, Korea, Saudi Arabia, Russia,
- Date initiated
- 2003-03-04
- Date posted
- 2003-03-21
- Date terminated
- 2006-02-07
- 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 |
|---|---|---|
| ECAT ACCEL PET SCANNER (K002584) | Cti Pet Systems, Inc. | 2000-11-16 |
| ECAT EXACT & ECAT EXACT HR+ (K962797) | Cti Pet Systems, Inc. | 1996-10-15 |
| ECAT PRT (K940478) | Cti Pet Systems, Inc. | 1994-03-22 |
| ECAT EXACT HR MODEL 961 (K920624) | Cti Pet Systems, Inc. | 1992-04-27 |
| ECAT SCANNER (MODEL 921) (K913637) | Cti Pet Systems, Inc. | 1991-11-27 |