The Recall Desk
HighFDA (Devices)·Z-2989-2018·Announced 2018-09-12

GE Vivid 7 Ultrasound System Recalled for Power Cord Shock Risk

GE Medical Systems is recalling 12,426 Vivid 7 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-harm product (electrical shock) where injury has not yet been reported, which aligns with the High severity criteria.

Plain-English summary

GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC is recalling 12,426 GE Vivid 7 ultrasound systems. The recall involves 4,717 units in the United States and 7,709 units outside the US. The Vivid 7 is a general-purpose ultrasound system specialized for cardiac imaging, intended for use by or under the direction of a qualified physician for various imaging applications.

The recall is due to a defect where the system side of the power cord may break and expose electrical conductors. This condition creates a risk of electrical shock to users or patients.

The affected units were distributed nationwide in the United States and Puerto Rico, as well as in numerous foreign countries including Canada, the United Kingdom, Germany, and Japan. 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 7 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 (i
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 · electrical shock

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