| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00370-1 |
| Product Name/Description |
LOGIQ S8 with software revisions R1.1.1 and R1.5.1, and LOGIQ S7 with software revisions R1.0.1, R1.0.2 and R1.0.3 (Diagnostic ultrasound system)
ARTG Number: 198951 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
24/04/2013 |
| Responsible Entity |
|
| Reason/Issue |
There is a potential for a skin burn when the flow model in the cardiac application is activated with the S4-10-D Ultrasound Probe. |
| Recall Action |
Recall |
| Recall Action Instructions |
GE is advising customers to discontinue activation of the “Flow Model” in the Cardiac Application when used with the S4-10-D ultrasound probe and is correcting the affected units permanently with a software update. |
| Contact Information |
1300 722 229 - GE National Service and Support Centre |