The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2987-2018·Announced 2018-09-12

GE Vivid E90 Ultrasound System Recalled for Electrical Shock Risk

GE Medical Systems is recalling Vivid E90 ultrasound systems because the power cord may break and expose electrical conductors, posing a risk of shock.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 electrical shock, which is a risk-of-harm product hazard. The source text does not report any injuries or illnesses, meeting the criteria for a High severity score.

Plain-English summary

GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC is recalling the GE Vivid E90 ultrasound system. The recall involves 12,426 units, with 4,717 units distributed in the United States and 7,709 units distributed outside the United States.

The recall is being conducted because the system side of the power cord may break and expose the electrical conductors. This defect creates a risk of electrical shock to users.

The affected systems are general-purpose ultrasound systems specialized for cardiac imaging, intended for use by or under the direction of a qualified physician. The distribution pattern includes the United States, Puerto Rico, and numerous foreign countries. Users should contact GE Medical Systems for further instructions on how to address the defect.

The recalled product

Product
GE Vivid E90 ultrasound system Product Usage: 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…
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 →

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