| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00359-1 |
| Product Name/Description |
Vivid and LOGIQ Ultrasound Systems
LOGIQ 9, LOGIQ E9, Vivid 7, Vivid E7, Vivid E9, Vivid E80, Vivid E90, and Vivid E95 ultrasound systems which have been installed since April 2015 or which have received a power cord replacement since April 2015.
ARTG Numbers: 126295, 146317 and 221395 |
| Recall Action Level |
Retail |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
1/05/2018 |
| Responsible Entity |
|
| Reason/Issue |
GE Healthcare has identified that the system side of the power cord for certain Vivid and LOGIQ Ultrasound Systems may break and expose the electrical conductors leading to the risk of shock. This can lead to injuries up to and including cardiac arrhythmia or cardiac arrest.
A minor injury has been reported overseas as a result of this issue. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
GE Healthcare will contact users to arrange for a replacement cord to be provided.
In the interim, users may continue to use their system until the correction has been implemented only if the system end of the cord is not damaged. Users should ensure all power to the unit is turned off prior to removal of the power cord.
This action has been closed out on the 16/10/2018. |
| Contact Information |
1800 659 465 - GE National Call Centre |