Print version of this report
TGA Action ID
RC-2026-RN-00137-1
Type of Product
Medical Device
Product Name/Description
Philips Azurion R2.1.10 and 2.2.10 Systems
Model Numbers: 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228, 722280, 722281, 722282
ARTG Number
225815, 370112
Action Type
Product Correction
Action Level
Hospital
Hazard Classification
Class II
Reason for the Action
Philips has identified six software problems affecting Azurion R2.1.10 and R.2.10 systems that may result in loss of imaging (X-ray) functionality, and/or loss of motorised movement, and/or incorrect image content, and/or loss of data.
Problem 1 - System keeps restarting
Problem 2 - AMC triple drive firmware – leading to movement problems
Problem 3 - C-Partition of Suite PC running out of free space
Problem 4 - System remains in continuous restart mode after the start-up
Problem 5 - Misalignment of Marker Tool Overlay
Problem 6 - 1- Longitudinal Position Error – Applicable only to Azurion systems with Poly-G3 frontal stand.
Instructions for Customers/Users
Customers should read the customer letter that outlines all the steps to mitigate these problems whilst awaiting a fix, which may include a cold restart.
Philips expects to have software update R2.1.15 or R2.2.15, that resolves the problems released by Q4 2026 (subject to regulatory clearance).
A local Philips representative will contact customers to schedule a visit to install the software updates once available.
UPDATE 11/8/2026: Philips had previously communicated in Feb 2026 that software update R2.x.15 was anticipated in Q4 2026. However, Philips now expects software update R2.x.15 to be available by March 2027 (subject to regulatory clearance).
Action Commencement Date
23/02/2026
Responsible Entity
Philips Electronics Australia Ltd
Contact Information
1800 251 400 - Philips Service Delivery Team