Company:GE Healthcare
Date of Enforcement Report:11/14/2007
Class:ll
PRODUCT
GE Healthcare Voluson E8 ultrasound scanner with Software version 6.2.0 and 6.2.1 and DICOM stations with these software versions; Recall # Z-0113-2008
REASON
When a spectrum of a Pulsed Wave Doppler shows an angle correction unequal to 0 is reloaded from the archive or the image is sent to a DICOM station, this angle correction is mistakenly disregarded resulting in an underestimation of the flow velocities.
RECALLING FIRM/MANUFACTURER
IRecalling Firm: GE Healthcare, Wauwatosa, WI, by letters on July 15, 2007.
Manufacturer: GE Medical Systems, Kretztechnik GmbH & Co. OHG, Zipf, Austria. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
521 units
DISTRIBUTION
Nationwide
