Recall Z-2098-2013— GE Healthcare, LLC

Name: FDA recall Z-2098-2013
Creator: U.S. Food and Drug Administration
Published: 2013-08-07

Class II · Terminated

Class II FDA medical device recall by GE Healthcare, LLC, initiated 2013-08-07, terminated 2014-04-25. It names one FDA 510(k) clearance: K103458. Product: GE Ultrasound ViewPoint 6. Product Usage: ViewPoint is intended to be used in medical practices and in clinical departments and serves the purposes of diagnostic interpretation of images, electronic documentation of examinations in the form of text and images and generation of medical reports primarily for diagnostic ultrasound. ViewPoint provides the user the ability to including images, drawings, and charts into medical reports. ViewPoint is designed to accept, transfer, display, calculate, store and process medical images and data, and enables the user to measure and annotate the images. The medical images, which ViewPoint displays to the user, can be used for diagnostic purposes. ViewPoint is intended for professional use only. ViewPoint is not intended to be used as an automated diagnosis system.. Reason: GE has recently become aware of a potential safety issue due to the incorrect calculation of the pulsatility index value (PIV) for venous flow measurements associated with obstetric reporting of the GE ViewPoint 6 system. The ViewPoint calculated Doppler PIV for veins could be incorrect. An incorrect calculation of the ductus venosus PIV could lead to false high risk for trisomy 13, 18, and 21,.

Recalling firm: GE Healthcare, LLC
Classification: Class II
Status: Terminated
Initiated: 2013-08-07
Terminated: 2014-04-25
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K103458 — VIEWPOINT 6GE Healthcare·cleared 2011-03-04

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

GE Ultrasound ViewPoint 6. Product Usage: ViewPoint is intended to be used in medical practices and in clinical departments and serves the purposes of diagnostic interpretation of images, electronic documentation of examinations in the form of text and images and generation of medical reports primarily for diagnostic ultrasound. ViewPoint provides the user the ability to including images, drawings, and charts into medical reports. ViewPoint is designed to accept, transfer, display, calculate, store and process medical images and data, and enables the user to measure and annotate the images. The medical images, which ViewPoint displays to the user, can be used for diagnostic purposes. ViewPoint is intended for professional use only. ViewPoint is not intended to be used as an automated diagnosis system.

Reason for recall

GE has recently become aware of a potential safety issue due to the incorrect calculation of the pulsatility index value (PIV) for venous flow measurements associated with obstetric reporting of the GE ViewPoint 6 system. The ViewPoint calculated Doppler PIV for veins could be incorrect. An incorrect calculation of the ductus venosus PIV could lead to false high risk for trisomy 13, 18, and 21,

Data sourced from openFDA. This site is unofficial and independent of the FDA.