Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 35560 |
| Brand Name: | Angiographic X-Ray |
| Model: | Philips Azurion Systems |
| Affected: | Multiple models |
| Software version: | |
| Recalling Organisation: | Philips New Zealand Commercial Limited Level 3 123 Carlton Gore Road Newmarket AUCKLAND 1023 |
| Contact Information: | 0800 251 400 |
| Manufacturer: | Philips Medical Systems Nederland BV |
| Brand Name: | Azurion |
| Model: | Philips Azurion R1.x and R2.x systems |
| Affected: | Multiple model numbers |
| Software version: | |
| Recalling Organisation: | Philips New Zealand Commercial Limited Level 3 123 Carlton Gore Road Newmarket AUCKLAND 1023 |
| Contact Information: | 0800 251 400 |
| Manufacturer: | Philips Medical Systems Nederland BV |
| Issue: | The manufacturer has identified a software issue in the internal communication process between the system software and the X-ray generator firmware. This issue may be triggered under either of the following situations: Situation 1 - Pedal Tap: When the foot switch is pressed and released rapidly without generating X-rays (due to a short duration of contact), the system may enter a state where X-ray generation is inhibited. When this occurs, the system does not show any message to the user indicating that X-ray is not possible. Situation 2 – Phase Fault: Azurion systems are designed to automatically recover from phase faults (a phase fault is an abnormal condition in which one or more phase voltages drop to (near) zero). When a phase fault occurs, the X-ray generator software initiates an automatic recovery process to restore full system functionality, during which imaging (X-ray) functionality is not available for approximately 5 seconds. |
| Recall action type: | Correction |
| Recall action: | Software to be upgraded |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 24/7/2025 |
