Allura and Azurion Systems — recall 77918

Reported risk: The 1 Phase UPS is an optional component that can be installed in Allura and Azurion systems to support a controlled shutdown of the PCs (the computers that control the system) in the event of a mains power failure. The 1 Phase UPS provides temporary power to the PCs, allowing the system to save the data of the last acquired run before the PCs shut down. Philips has become aware of a potential safety issue with Philips Azurion and Allura systems configured with a 1 Phase uninterruptible power supply (UPS). Philips has identified that some internal components of the 1 Phase UPS may fail. When this occurs, there will be a complete loss of power to the system, causing the system to shut down and/or not start up. The 1 Phase UPS system may fail without warning and prior to any mains power failure. If the system does not start up or the system shuts down, there is a potential risk of delay or termination of the procedure. The potential delay in treatment and/or termination of the procedure may result in serious adverse health outcomes, including the possibility of death, especially when the system is used with critical patients, particularly those undergoing complex and/or urgent interventions for potentially life-threatening conditions (e.g., acute ischemic stroke, st-segment elevation myocardial ischemia). Recall start date: July 31, 2025