The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2988-2018·Announced 2018-09-12

GE Vivid E95 Ultrasound System Recalled for Power Cord Shock Risk

GE Medical Systems is recalling 12,426 Vivid E95 ultrasound systems because the power cord may break and expose electrical conductors, creating a shock hazard.

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-harm product (electrical shock) where injury has not yet been reported, which corresponds to a score of 3 (High) per the rubric.

Plain-English summary

GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC is recalling 12,426 GE Vivid E95 ultrasound systems. The recall affects 4,717 units in the United States and 7,709 units in other countries. The devices are intended for use by qualified physicians for various ultrasound evaluations, including fetal, abdominal, pediatric, and cardiac imaging.

The recall is being issued because the system side of the power cord may break and expose the electrical conductors. This defect leads to a risk of electrical shock. The affected units were distributed nationwide in the United States, in Puerto Rico, and in numerous foreign countries.

Each consignee has one serial number assigned to the affected units. Users should stop using the affected devices and contact GE Medical Systems for instructions on repair or replacement.

The recalled product

Product
GE Vivid E95 ultrasound system Product The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal (including renal and GYN); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and…
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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