OFFICIAL-SOURCE RECALL · AUSTRALIA
Azurion R2.x.10, R3.0, R3.1 and R4.0 systems Recall: Classification Class II Reason for the Action
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- Azurion R2.x.10, R3.0, R3.1 and R4.0 systems
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Why this product was recalled
Classification Class II Reason for the Action Philips 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. Instructions for Customers/Users Customers should note: · Problem 1: Image quality degradation If image quality degradation is observed, perform a cold restart of the system as soon as clinically feasible, following the steps described in the Instructions
Hazard
Classification Class II Reason for the Action Philips 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. Instructions for Customers/Users Customers should note: · Problem 1: Image quality degradation If image quality degradation is observed, perform a cold restart of the system as soon as clinically feasible, following the steps described in the Instructions
Official recall notice
Azurion R2.x.10, R3.0, R3.1 and R4.0 systems
Agency: Therapeutic Goods Administration
Official publication date: August 10, 2026
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