The Recall Desk
HighFDA (Devices)·Z-2983-2018·Announced 2018-09-12

GE LOGIQ E9 Ultrasound System Recalled for Power Cord Shock Risk

GE Medical Systems is recalling 12,426 LOGIQ E9 ultrasound systems because the power cord side may break, exposing electrical conductors and creating 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 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 LOGIQ E9 ultrasound systems. The recall involves 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, cardiac, and vascular imaging.

The recall is due to a defect where the system side of the power cord may break, exposing electrical conductors. This condition creates a risk of electric shock to users. 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 contact GE Medical Systems for instructions on how to resolve the issue, which may involve repair or replacement of the power cord or system.

The recalled product

Product
GE LOGIQ E9 ultrasound system Product Usage: The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral V
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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