Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 34168 |
| Brand Name: | Angiographic X-Ray |
| Model: | Philips Allura Xper R7.6- R8.1 systems |
| Affected: | |
| 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: | 22/10/25: Update - The maufacturer initiated Corrective Action 2024-IGT-BST-010 to correct Allura R7.6 and R8.1 systems that have exceeded their 10-year service life, and for which the propeller motor clamping bolt and the X-ray tube locking bolt had not been replaced. This action was taken due to the potential risk of bolt failure. However, following further investigation, the manufacturer has confirmed that the initially suspected failure mechanisms—hydrogen embrittlement and fatigue - do not apply. Therefore, replacement of these bolts is not required. The manufacturer has identified potential safety issues with delayed LTE kit installations for Allura R7.6-R8.1 systems exceeding 10 years of life. The kit includes a propeller motor clamping bolt and the X-ray tube locking bolt. If one of these bolts breaks, part of the system will not function as expected. |
| Recall action type: | Correction |
| Recall action: | Product to be modified |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 22/10/2025 |
