| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00069-1 |
| Product Name/Description |
Philips EPIQ Series Ultrasound Systems
Systems manufactured between 18/09/2023 to 08/11/2023.
ARTG 93851
(Philips Electronics Australia Ltd Ultrasound system, imaging, general-purpose) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
29/01/2024 |
| Responsible Entity |
|
| Reason/Issue |
Time Gain Compensation (TGC) Slide Controls may become unresponsive after multiple start-ups/reboots of the EPIQ Ultrasound System. Rebooting the system may not recover the TGC Slide Controls.
TGC Slide Controls are used to make small 2D gain manipulations across the 2D image. Each of these Slide Controls are used to adjust the brightness range of gain compensation over a unique region of the 2D image.
Philips has received complaints associated with this issue, however, there have been no reports of injury or serious harm. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Philips will contact affected customers to install a firmware update to permanently resolve the issue.
In the interim customers can continue to use the device in accordance with their intended use.
The customer letter (supplied to affected customers) contains work around instructions for 2D image gains. |
| Contact Information |
1800 251 400 - Philips Service Delivery Team |