15
Nov
2007

GE Healthcare Voluson E8 ultrasound scanner Cl II

0

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

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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