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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