Company:GE Medical Systems, LLC
Date of Enforcement Report 8/26/2009
Class:ll
PRODUCT
GE Healthcare, CT Perfusion 4 on Advantage Workstation, CT and PET/CT consoles. Image analysis software package that allows the user to produce image data and to generate information with regard to changes in image intensity over time supporting CT Perfusion images, Recall # Z-1720-2009
REASON
GE Healthcare has recently become aware of the need to adjust default settings associated with the use of CT Perfusion 4 on the Advantage Workstation, ST and PET/CT consoles that may impact patient safety. The default parameter settings in CT Perfusion 4 may not be optimal in the case of data acquired with longer time sampling intervals such as axial scans with inter scan delay (ISD) greater than 2 seconds of Volume Shuttle date. This can result in reduced conspicuity of subtle perfusion defects due to increased noise in these types of data sets.
RECALLING FIRM/MANUFACTURER
Recalling Firm: GE Medical Systems, LLC, Waukesha, WI, by letter dated October 23, 2009.
Manufacturer: GE Medical Systems, SCS, Buc Cedex, France. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
444 units
DISTRIBUTION
Nationwide and Internationally
