GE Voluson E8 Ultrasound System

• • Terminated Z-0541-2010 FDA Unclassified (pre-2012) ·initiated 22 Oct 2009

  GE Healthcare has recently become aware of an incorrect operating procedure associated with software versions 9.0.0, 9.0.1, and 9.0.2 of the Voluson E6 or Voluson E8 Diagnostic Ultrasound Systems that may impact patient safety. When using the combination of 2D-CRI and PW with a steered Doppler angle, the displayed velocity scale is incorrect. The consequence can be an underestimation of flow v

• • Terminated Z-2404-2008 FDA Unclassified (pre-2012) ·initiated 1 Apr 2008

  Inaccurate dimension measurements in M-Mode when pan-Zoom is activated in GE Voluson E8 Ultrasound Systems. Of particular concern are potential inaccuracies of fetal cardiac measurements that may impact patient safety.

• • Terminated Z-0113-2008 FDA Unclassified (pre-2012) ·initiated 6 Jul 2007

  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.

510(k) Number

K061682 ↗

FDA Product Code

IYO

Device Class

Class II

Regulation

21 CFR Part 892.1560

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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