Official recall record

Azurion 3 and 7

What the authority reported

Philips has identified two issues in software version R1.X of the Philips Azurion system that may affect: a) Management of the system log trace files: The mechanism that is present in the system to manage the number and size of the system log trace files does not function properly, as a result of which the log trace files related to remote connection logging may occupy the full hard disk capacity of the Philips Azurion R1.X system. When the full disk capacity is reached, imaging (X-ray) functionality will cease to be available without an advance warning to the user. A restart of the system will not resolve the issue. Note: This issue only impacts the Philips Azurion R1.X systems that are currently connected to Philips remote service or that were connected in the past. b) Time to perform a cold restart: A cold restart of the Philips Azurion R1.X system may take up to 6 minutes as stated in the instructions for use of the system (section 4.2). This time includes the time required for the system to shut down and the system to start up. However, there are instances where the shutdown of the system may be prolonged (with up to 4 minutes) resulting in the cold restart taking longer (up to 10 minutes in total). Recall Start Date: July 17, 2024

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

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