Health product recall

LOGIQ P6 Ultrasound System - Main Unit and LOGIQ P6 Ultrasound System - Console Upgrade to BT09 (2018-12-27)

Starting date:
December 27, 2018
Posting date:
January 23, 2019
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-68852

Affected products

  1. LOGIQ P6 Ultrasound System - Main Unit
  2. LOGIQ P6 Ultrasound System - Console Upgrade to BT09

Reason

In rare instances, if a certain component fails, there is a potential of increased temperature in the probe-head surface when using these scanners with specific probes. This could result in a burn to the patient in specific types of scans.

Affected products

A. LOGIQ P6 Ultrasound System - Main Unit

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

H46082LW

Companies
Manufacturer

GE Ultrasound Korea Ltd.

9 Sunhwan-ro 214beon-gil

Jungwon-gu. Seongnam, Gyeonggi

462-807

SOUTH KOREA

B. LOGIQ P6 Ultrasound System - Console Upgrade to BT09

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

H46172LJ

Companies
Manufacturer

GE Ultrasound Korea Ltd.

9 Sunhwan-ro 214beon-gil

Jungwon-gu. Seongnam, Gyeonggi

462-807

SOUTH KOREA