| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00361-1 |
| Product Name/Description |
Zenition 70 systems
Model Number: 718133
ARTG 235144, 405770 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
8/05/2024 |
| Responsible Entity |
|
| Reason/Issue |
There is a possibility of unintended radiation exposure while using the wired footswitch or handswitch.
The requirement from the standard states that X-ray stop time should not exceed 100 milliseconds once the footswitch or handswitch is released to stop the X-ray. However, there might be a possibility when a Zenition 70 system is used in 2fps subtract mode for a vascular surgery procedure, the time to stop X-ray might exceed by 18 milliseconds over and above the 100 milliseconds. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
A Philips representative will contact all affected customers to schedule a Field Service Engineer visit to update the software free of charge. |
| Contact Information |
1800 251 400 - Philips Service Delivery Team |