| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2022-RN-01494-1 |
| Product Name/Description |
Philips ProxiDiagnost N90 1.1
Model Number: 706110
Multiple serial numbers
ARTG 340852
(Philips Electronics Australia Ltd - X-ray system, diagnostic, fluoroscopic, general-purpose, stationary, digital) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
13/12/2022 |
| Responsible Entity |
|
| Reason/Issue |
Philips has identified two issues with the Philips ProxiDiagnost N90 1.1 system that could pose a risk for patients or users. Customers may encounter one or both of the following issues: potential component damage due to short circuit and potential table stop due to a broken tabletop cable.
There have been no adverse events reported to Philips as of October 2022. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Philips are advising that if users see or smell smoke or hear a popping noise from the M-cabinet to immediately remove power to the room using the main circuit breaker and remove the patient. Similarly, if the table is not tilting or braking as expected, users should bring the table back to 0° position using the Tilting Switch and remove the patient off the table.
Philips will be visiting impacted facilities to update the system with a hardware component and will replace the tabletop cable to prevent both issues from occurring in Q1 2023. |
| Contact Information |
1800 251 400 - Philips Service Delivery Team |