GE Vivid E9 Diagnostic Ultrasound Imaging System

• • Terminated Z-0373-2014 FDA Class II ·initiated 11 Oct 2013

  GE became aware of a potential safety issue due to a system slow down and system lock up associated with the software of Vivid E9 ultrasound system. During a critical procedure the Vivid E9 Scanner may gradually become unresponsive and eventually lock up, with the result that the vivid E9 Scanner must be rebooted.

510(k) Number

K120201 ↗

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

  Class II

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• P2D

  Class IIa

  CE/MDR GUDID on market

See all devices from GE Vingmed Ultrasound AS →