Company:Siemens Medical Solutions USA, Inc.,
Date of Enforcement Report:12/5/2007
Class:ll
PRODUCT
a) Siemens ECAT ACCEL, Catalog No. 3545584, PET/CT Scanner,
Recall # Z-0269-2008;
b) Siemens ECAT ART, Catalog No.. 3545584, PET/CT Scanner,
Recall # Z-0270-2008;
c) Siemens ECAT EXACT 47, Catalog No. 1788772, PET/CT Scanner,
Recall # Z-0271-2008;
d) Siemens ECAT EXACT HR 47, Catalog No. 2956261, PET/CT Scanner,
Recall # Z-0272-2008;
e) Siemens ECAT EXACT HR+, Catalog No. 3548083, PET/CT Scanner,
Recall # Z-0273-2008
REASON
Incorrect Decay Correction Results – ECAT System’s software versions 7.2.2 and 7.4 calculate the decay correction for emission data incorrectly, while performing whole-body studies with all transmissions followed by all emissions.
RECALLING FIRM/MANUFACTURER
Incorrect Decay Correction Results – ECAT System’s software versions 7.2.2 and 7.4 calculate the decay correction for emission data incorrectly, while performing whole-body studies with all transmissions followed by all emissions..
VOLUME OF PRODUCT IN COMMERCE
441 units
DISTRIBUTION
Nationwide and Internationally
