The Recall Desk
HighFDA (Devices)·Z-2985-2018·Announced 2018-09-12

GE Vivid E9 Ultrasound System Recalled for Power Cord Shock Risk

GE Medical Systems is recalling 12,426 Vivid E9 ultrasound systems because the power cord may break and expose electrical conductors, posing a risk of electric shock.

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 specific 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 12,426 GE Vivid E9 ultrasound systems. These are general-purpose ultrasound systems intended for use by or under the direction of a qualified physician for various imaging applications, including cardiac, fetal, and abdominal imaging.

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 electric shock to users or patients.

The affected units were distributed nationwide in the United States and Puerto Rico, as well as to numerous foreign countries. Each consignee has one serial number assigned to the affected units. Users should contact GE Medical Systems for instructions on how to address the defect.

The recalled product

Product
GE Vivid E9 ultrasound system Product Usage: GE Vivid E9 ultrasound system is a general purpose ultrasound system for use in cardiac imaging. It is intended for use by, or under direction of a qualified physician for ultrasound imaging and analysis of Fetal; Abdominal (in
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

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Same hazard · electric shock

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