The Recall Desk
SevereFDA (Devices)·Z-2990-2018·Announced 2018-09-12

GE Vivid E7 Ultrasound System Recalled for Power Cord Shock Risk

GE Medical Systems is recalling Vivid E7 ultrasound systems because the power cord may break and expose electrical conductors, creating a risk of electric shock.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a risk of electric shock, which aligns with the rubric criteria for significant injury reports or high-risk electrical hazards.

Plain-English summary

GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC is recalling the GE Vivid E7 ultrasound system. This general-purpose ultrasound system is specialized for cardiac imaging and is intended for use by or under the direction of a qualified physician for various imaging applications, including fetal/obstetrics, abdominal, pediatric, and cardiac.

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

A total of 12,426 units are affected, with 4,717 units in the United States and 7,709 units distributed outside the United States. The products were distributed nationwide, in Puerto Rico, and in numerous foreign countries. Each consignee has one serial number assigned. Users should contact GE Medical Systems for instructions on how to address the defect.

The recalled product

Product
GE Vivid E7 ultrasound system Product Usage: Vivid E7 is a general-purpose ultrasound system, 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/Obstetrics; Abdominal (
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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