Allura and Azurion Systems
Summary
Contact the manufacturer if you require additional information.
Affected products
Affected products | Lot or serial number | Model or catalog number |
---|---|---|
Allura Xper FD20 | 878 | 722028 |
Allura Xper FD20 | 231 | 722028 |
Allura Xper FD20 | 1572 | 722028 |
Allura Xper FD20 | 1039 | 722028 |
Allura Xper FD20 | 758 | 722028 |
Allura Xper FD20 | 663 | 722028 |
Allura Xper FD20 | 942 | 722028 |
Allura Xper FD20 | 763 | 722028 |
Allura Xper FD20 OR Table | 128 | 722035 |
Allura Xper FD20 OR Table | 111 | 722035 |
Azurion 7 B12 | 128 | 722 067 |
Azurion 7 B12 | 151 | 722 067 |
Azurion 7 B20 | 265 | 722 068 |
Azurion 7 B20 | 275 | 722 068 |
Allura Xper FD10 | More than 10 numbers, contact manufacturer. | 722026 |
Azurion 7 M12 | More than 10 numbers, contact manufacturer. | 722 223 |
Azurion 7 M12 | More than 10 numbers, contact manufacturer. | 722 078 |
Azurion 7 M20 | More than 10 numbers, contact manufacturer. | 722 224 |
Azurion 7 M20 | More than 10 numbers, contact manufacturer. | 722 079 |
Issue
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
Additional information
Details
Philips Medical Systems Nederland B.V.
Veenpluis 6, Best, Netherlands, 5684 PC
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