The Recall Desk
HighFDA (Devices)·Z-2986-2018·Announced 2018-09-12

GE Vivid E80 Ultrasound System Recalled for Power Cord Shock Risk

GE Medical Systems is recalling Vivid E80, E90, and E95 ultrasound systems because the power cord may break and expose electrical conductors, creating a shock hazard.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk of electric shock, which is a risk-of-harm product hazard. The source text does not report any injuries or illnesses, placing this in the 'High' category per the rubric for risk-of-harm products where injury has not yet been reported.

Plain-English summary

GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC is recalling the GE Vivid E80, E90, and E95 ultrasound systems. These are general-purpose ultrasound systems specialized for cardiac imaging and other medical applications. The recall involves 12,426 units, with 4,717 located in the United States and 7,709 outside the U.S.

The recall is due to a defect where the system side of the power cord may break, exposing electrical conductors. This condition creates a risk of electric shock to users. The affected units were distributed nationwide in the U.S., in Puerto Rico, and in numerous foreign countries.

Healthcare facilities and users should contact GE Medical Systems for instructions on how to address the defect. The source text does not specify a particular action such as stopping use or returning the device, but users should follow the manufacturer's guidance to mitigate the shock risk.

The recalled product

Product
GE Vivid E80 ultrasound system Vivid E80 / E90 / E95 ultrasound system is general-purpose ultrasound systems, specialized for use in cardiac imaging. It is intended for use by, or under the direction of a qualified physician for ultrasound imaging and analysis of fetal/Obstetr
Manufacturer
GE Medical Systems Ultrasound & Primary Care Diagnostics, LL
Category
Medical Device — Ultrasound System
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Each consignee have one serial numbers assigned

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 8 recalled by GE Medical Systems Ultrasound & Primary Care Diagnostics, LL under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 8 products in this recall →

Related recalls

Same manufacturer · GE Medical Systems Ultrasound & Primary Care Diagnostics, LL

See all →

Same hazard · electric shock

See all →