Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:35410
Brand Name:Angiographic X-Ray
Model:Azurion 7M20 system
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 that the bolts connecting the gearbox to the mounting flange of the C-arm roll motor may have not been adequately torqued. The C-arm roll motor is located on the side of the C-arm and drives the roll motion of the C-arm Over time, if the bolts are not adequately torqued, they may get loose and cause minor shift movements of the gearbox relative to the mounting flange. These movements may cause (unexpected) noise during the C-arm roll motion. The misalignment between the gearbox and the mounting flange may be detected by the C-arm positioning software in which case, the message Motorized movement is not available will be shown to the user and motorized roll and propellor movements of the C-arm will be disabled. Motorized longitudinal stand movement, stand rotation and detector movements will remain available. A warm or a cold restart may temporarily resolve the issue.
Recall action type:Correction
Recall action:Product to be exchanged
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:18/6/2025
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