Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:36986
Brand Name:Allura Angiographic X-Ray
Model:System code: 722003 - Allura Xper FD10
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:System code: 722079 - Azurion 7 M20, System code: 722221 - Azurion 3 M12, System code: 722224 - 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 through customer complaints that, during certain repair or service actions, HDDs with different performance characteristics than those specified by the legal manufacturer may have been installed. These HDDs may exhibit reduced reliability over time, which may result in loss of imaging functionality. Additionally, in Allura systems, this may lead to loss of motorised movement or loss of data.
In addition, the manufacturer has identified that in some Allura systems, HDDs compliant with specifications but of different types have been used within a single system, whereas specifications require identical HDD types.
Recall action type:Correction
Recall action:Product to be exchanged
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:2/7/2026
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