| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00287-1 |
| Product Name/Description |
5000 Compact Series Ultrasound Systems
Model numbers: 5500, 5300
ARTG 408664
(Philips Electronics Australia Ltd - Ultrasound system, imaging, general-purpose) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
10/04/2024 |
| Responsible Entity |
|
| Reason/Issue |
There is a problem with the multiport adapter resulting in a transducer continuing to receive power and exceed established temperature limits, which has the potential to cause burns in the oesophagus. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Philips will contact customers to schedule a time for a Field Service Engineer to visit their site and implement the solution to resolve the problem. Philips anticipate the correction to be available by June 2024. |
| Contact Information |
1800 251 400 - Philips Service Delivery Team |