Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0373-2014 — GE Vivid E9 ultrasound system. GE Vivid E9 is a Track 3 diagnostic ultrasound system, which is primarily intended for cardiac imaging and analysis, but which also includes vascular and general radiology applications. The Vivid E9 incorporates a variety of electronic array transducers operating in

U.S. FDA — Device Enforcement · United States · 2013-10-11 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0373-2014
Date of alert: 2013-10-11
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: GE Healthcare, LLC
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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