Company: Siemens Medical Solutions USA, Inc,
Date of Enforcement Report:5/3/2006
Class:lI
PRODUCT
Somatom Sensation CT Systems, Sensation 10, model number 7543015,
Sensation 16, model number 7393114, Sensation 64, model number 8377520, and
Sensation Open model number 8872017, Recall # Z-0797-06
REASON
Firm became aware of a potential problem that could affect scan results and require patient exam to be repeated when using the customized ECG-gated scan protocols in the CT2006A and CT2006G software of their SOMAtOM Sensation CT Systems.
CODE
Software versions CT2006A and CT2006G
RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Solutions USA, Inc, Malvern, PA, by letter on March 28, 2006.
Siemens Medical Solutions, Forchheim, Germany, firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
86 units
DISTRIBUTION
Nationwide