Company: Siemens Medical Solutions USA, Inc.
Date of Enforcement Report 12/10/2008
Class:lll
PRODUCT
syngo MultiModality WorkPlace (MM WP). Software product (Model Number 10140720). The product is intended for use in picture archiving and communications system; Recall # Z-0324-2009
REASON
Values derived from Dynamic CT data sets may be incorrect. The corresponding images are not affected.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Solutions USA, Inc., Malvern , PA , by visit beginning September 12, 2008.
Manufacturer: Siemens Medical Solutions Inc., Erlangen , Germany . Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
84 units
DISTRIBUTION
Nationwide
