Health product recall

Allura and Azurion Systems

Last updated

Summary

Product
Allura and Azurion Systems
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

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
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Radiology
Companies

Philips Medical Systems Nederland B.V.

Veenpluis 6, Best, Netherlands, 5684 PC

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-77918

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