GE Vivid E9 Diagnostic Ultrasound Imaging System

• • Terminated Z-2985-2018 FDA Class II ·initiated 22 Mar 2018

  The system side of the power cord may break and expose the electrical conductors leading to the risk of shock.

• • Terminated Z-1488-2014 FDA Class II ·initiated 27 Mar 2014

  GE Healthcare has recently become aware of a potential safety issue where the probe power surveillance settings for 4 probes (C1-5-D, C2-9-D, IC5-9-D and M5Sc-D) are incorrect. This may result in a situation where probes can overheat.

510(k) Number

K131514 ↗

FDA Product Code

IYN

Device Class

Class II

Regulation

21 CFR Part 892.1550

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• GE Vivid E9 Diagnostic Ultrasound Imaging System

  Class II

  FDA 510(k) K101149 Active Cleared 13 Oct 2010

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  CE/MDR FDA 510(k) K141093 Active Cleared 15 May 2014

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  FDA 510(k) K101324 Active Cleared 5 Oct 2010

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  FDA 510(k) K092756 Active Cleared 28 Sep 2009

• Vivid E80 Diagnostic Ultrasound Imaging System, Vivid E90 Diagnostic Ultrasound Imaging System, Vivid E95 Diagnostic Ultrasound Imaging System Open recall

  Class II

  CE/MDR FDA 510(k) K150087 Active Cleared 4 Mar 2015 +1authorizations

• P2D

  Class IIa

  CE/MDR GUDID on market

See all devices from GE Vingmed Ultrasound AS →