| TGA Action ID |
RC-2026-RN-00705-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Philips BV Pulsera and Zenition Systems
BV Pulsera 2.3
Model Number: 718095
Serial Numbers: 518, 2884, 3452, 4044, 4594
Zenition 70
Model Number: 718133
Serial Numbers: 1899, 2215, 3027, 3683, 4256, 5449 |
| ARTG Number |
235144, 405770 |
| Unique Device Identifier (UDI) |
N/A |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class I |
| Reason for the Action |
Philips identified a potential problem affecting Mobile Interventional X-ray Systems equipped with specific monoblocks. The monoblock is the component responsible for generating X-rays used during clinical procedures.
Air bubbles may develop in the monoblock oil when there is a prolonged period between manufacture and installation, for example due to storage, transportation, or other pre-installation holding time.
During a clinical procedure, when the user activates X-ray imaging, if an air bubble becomes trapped in the high-voltage area of the monoblock, there could be an internal electrical discharge (flashover) resulting in X-rays not being generated and consequently no image being displayed on the examination monitor. When this situation occurs, the system displays an error message indicating that the X-ray generator is not available. In some cases, restarting the system (which takes approximately 5 minutes) may restore X-ray generation.
Philips' investigation indicates that this problem may occur during the early period of system use following a prolonged period between manufacture and installation. Based on the investigation, potentially affected systems have been identified as those for which more than 300 days elapsed between manufacture and installation and fewer than 250 days have elapsed since installation. |
| Instructions for Customers/Users |
A Philips representative will contact users to schedule a service visit. For monoblocks that support conditioning, Philips will perform a conditioning procedure to remove potential air bubbles from the oil. For monoblocks that do not support conditioning, Philips will inspect the monoblock and replace the monoblock when air bubbles are observed. Philips expects to begin implementation of the correction starting in September 2026.
Customers may continue to use the system in accordance with the instructions for use. However, clinicians should consider use of alternate devices for procedures that are highly dependent on continuous live X-ray guidance.
If the system displays an X-ray generator unavailable message or fails to generate X-rays, restart the system according to the instructions displayed-on system screen. Report the occurrence to the local Philips representative, even if X-ray generation is restored after the restart. |
| Action Commencement Date |
24/09/2026 |
| Responsible Entity |
|
| Contact Information |
1800 251 400 - Philips Service Delivery Team |