| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2023-RN-00526-1 |
| Product Name/Description |
Vivid S60 / Vivid S70 / Vivid S60N / Vivid S70N Ultrasound Systems
Vivid S60 v203, v204
Vivid S70 v203, v204.
Vivid S60N v203, v204, v205, v206
Vivid S70N v203, v204, v205, v206
ARTG 221395
(GE Healthcare Australia Pty Ltd - Ultrasound system, imaging, cardiovascular) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
22/06/2023 |
| Responsible Entity |
|
| Reason/Issue |
GE HealthCare has become aware that certain Vivid ultrasound systems may not boot up in a timely fashion. If this occurs, it can delay availability of the device in time-critical emergency situations.
You can continue to use your device. Please follow clinical practice guidelines, which include having a backup imaging plan when performing time-critical examinations or image-guided interventions. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
GE will contact customers to inform that they can continue to use the device after following clinical practice guidelines which include having a backup imaging plan when performing time-critical examinations or image-guided interventions.
GE will also inform the customers that the issue will be corrected by updating BIF firmware and application software. Customers can order FMI kits till 01/09/2023. |
| Contact Information |
1800 659 465 - Healthcare Service - GE |