Company: Cti Pet Systems, Inc
Date of Enforcement Report: 4/9/03
Class: II
PRODUCT
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.
Recall # Z-0674-03.
REASON
Incorrect patient information is displayed in the reconstructed images of a whole body patient scan.
CODE
All serial numbers of above indicated scanner models using ECAT System Software Versions V7.1.1b, V7.2, V7.2.1 and V7.2.2.
RECALLING FIRM/MANUFACTURER
Cti Pet Systems, Inc., Knoxville, TN, by letter beginning on March 4, 2003. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
444.
DISTRIBUTION
Nationwide and Internationally.
