Company: Siemens Medical Solutions
Date of Enforcement Report: 4/30/03
Class: III
PRODUCT
ICON 9.5 Software used on the ICON workstations designed for use with the E.CAM Emission Imaging Computed Tomography Systems. Recall # Z-0727-03.
REASON
ICON 9.5 software does not apply flood corrections during whole body SPECT studies with multiple bed positions.
CODE
All Diacam, Multispect 2, Multispect 3 and e.cam camera systems with ICON workstations with ICON software version 9.5 and the optional Whole Body SPECT software.
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions, USA, Inc., Hoffman Estates, IL, by letters dated February 10, 2003. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
600 units.
DISTRIBUTION
Nationwide and Internationally.
