Azurion 7 Systems — recall 77587

Reported risk: Philips has identified a software issue in the internal communication process between the system software and the X-ray generator firmware. This issue may be triggered under either of the following situations: Situation 1 - Pedal Tap: When the foot switch is pressed and released rapidly without generating X-rays (due to a short duration of contact), the system may enter a state where Xray generation is inhibited. When this occurs, the system does not show any message to the user indicating that X-ray is not possible. A warm restart may resolve the situation in some cases. A cold restart will always resolve the situation. Situation 2 - Phase Fault: Azurion systems are designed to automatically recover from phase faults (a phase fault is an abnormal condition in which one or more phase voltages drop to (near) zero). When a phase fault occurs, the X-ray generator software initiates an automatic recovery process to restore fully system functionality, during which imaging (X-ray) functionality is not available for approximately 5 seconds. When the identified software issue occurs during this recovery, communication with the system software is lost, resulting in the system not recognizing that the generator has recovered and is ready for operation. In this situation, the system shows the user message "generator is busy starting up, no X-ray possible". If the phase fault is detected by the generator during acquisition, the system also shows the message "run aborted: tube problem". To restore system functionality a cold restart of the system is required. Recall start date: June 4, 2025