The Recall Desk
HighFDA (Devices)·Z-2984-2018·Announced 2018-09-12

GE LOGIQ 9 Ultrasound System Recalled for Power Cord Shock Risk

GE Medical Systems is recalling 12,426 LOGIQ 9 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 in the rubric.

Plain-English summary

GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC is recalling 12,426 GE LOGIQ 9 ultrasound systems. The recall covers 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.

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.

The affected units were distributed nationwide and in Puerto Rico, as well as in numerous foreign countries including Canada, the United Kingdom, Germany, and Japan. Consumers and healthcare facilities should stop using the affected devices and contact GE Medical Systems for instructions on repair or replacement.

The recalled product

Product
GE LOGIQ 9 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
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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