Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 34661 |
| Brand Name: | Angiographic X-Ray |
| Model: | Allura Xper FD10, AlluraXper FD10/10, AlluraXper FD20, AlluraXper FD20 Biplane, AlluraXperFD20/15 |
| 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 |
| Brand Name: | [MDR] Azurion |
| Model: | Azurion 3 M12, Azurion 5 M12, Azurion 5 M20, Azurion 7 B12, Azurion 7 B20, Azurion 7 M12, Azurion 7 M20 |
| 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: | The manufacturer has identified in some situations that may result in the patient falling from the table related to the mattress used on the patient table of the Philips Allura and Azurion systems. Mattress movement during patient transfer and/or incorrect positioning or incorrect mattress used, may lead to a patient fall which might result in harm to the patient (e.g. hematoma/bruises, scratches, skin abrasions, stiffness, contusions, intracranial hemorrhage, large/complex lacerations), and potentially may result in death. All Philips Allura and Azurion systems used with a Philips mattress are affected. |
| Recall action type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 13/2/2025 |
