Recall Z-0674-03 ยท KPS System, Tomography, Computed, Emission
Cti Pet Systems Inc
ECAT Software Versions V7.1.1b, V7.2, V7.2.1, and V7.2.2 used in the following PET (Positron Emission Tomography) systems: Siemens Models: ECAT EXACT, ECAT EXACT HR, ECAT EXACT HR+, ECAT ART, ECAT EMERGE and ECAT ACCEL CTI Models: ECAT EXACT, ECAT EXACT HR+, ECAT ART, ECAT EMERGE, ECAT ACCEL, REVEAL QS and REVEAL XL Marconi Models: Magellan Hitachi Models: Sceptre and Sceptre XL
| Date | Mar 21, 2003 (initiated Mar 4, 2003) |
| Status | Terminated |
| Reason | Incorrect patient information is displayed in the reconstructed images of a whole body patient scan. |
| Root cause | Other |
| Action | Written notification was sent via letter with corrective software beginning on March 4 to the end users. |
| Quantity | 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, PROC (China), Czech Republic, Denmark, Mexico, Slovakia, and Chile |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K002584 | ECAT ACCEL PET SCANNER Cti Pet Systems, Inc., Nov 16, 2000 |
| K913637 | ECAT SCANNER (MODEL 921) Cti Pet Systems, Inc., Nov 27, 1991 |
| K920624 | ECAT EXACT HR MODEL 961 Cti Pet Systems, Inc., Apr 27, 1992 |
| K940478 | ECAT PRT Cti Pet Systems, Inc., Mar 22, 1994 |
| K962797 | ECAT EXACT & ECAT EXACT HR+ Cti Pet Systems, Inc., Oct 15, 1996 |