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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