Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:37228
Brand Name:Angiographic X-Ray
Model:a Philips Azurion R2.x.10, R3.0, R3.1 and R4.0 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
Brand Name:[MDR] Azurion
Model:Azurion R3.0 systems are affected by these issues. Issue 2 - Loss of geometry movements only affects Azurion R3.0 systems equipped with an AD7X patient table.
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 2 potential problems that may lead to delay of therapy, procedural complications and/or inappropriate treatment.
· Problem 1: Image quality degradation
A problem associated with the Flat Detector Controller System Interface Board (FDCSIB), may result in image artifacts during
system operation. The observed artifacts may include black and white dot noise, grainy or cloudy image quality, snow-like
effects, and random pixelation.
· Problem 2: Loss of geometry movements – Applicable to systems with an AD7X table only
In some cases, following a system (re)start, manual and motorised geometry movements may be disabled due to a firmware problem in the Advanced Motion Controller (AMC) single-axis motion control unit used in the AD7X table of Azurion systems. When the problem occurs, no message is displayed to the user. In this situation, X-ray imaging remains available.
Recall action type:Correction
Recall action:Software to be upgraded
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:10/8/2026
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