Official recall record

Philips Azurion System

What the authority reported

Philips has identified a safety issue affecting certain Azurion systems potentially leading to loss of imaging functionality. The power distribution unit is an internal assembly of the Philips Azurion system that contains multiple power supplies. Philips has identified that, in certain Azurion systems, one or more of these power supplies can fail due to energy peaks (surge voltages) during start or restart of the system. When a power supply failure occurs during a start or restart, the power distribution unit does not provide the required direct current power to essential system components. As a result, the system does not successfully complete the (re-)start, imaging functionality is unavailable, and the system remains unavailable for clinical use.

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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