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
- LOGIQ P6 Ultrasound System - Main Unit
- 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