Health product recall

Philips Azurion System

Last updated

Summary

Product
Philips Azurion System
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 catalogue number

Azurion 7 M20

Not applicable.

722 224

Azurion 7 M20

Not applicable.

722 079

Azurion 7 B12

Not applicable.

722 067

Azurion 7 M12

Not applicable.

722 223

Azurion 7 M12

Not applicable.

722 078

Azurion 7 B20

Not applicable.

722 226

Azurion 7 B20

Not applicable.

722 068

Issue

Philips has identified a safety issue affecting certain Azurion systems potentially leading to loss of imaging functionality. 
The power distribution unit is an internal assembly of the Philips Azurion system that contains multiple power supplies. Philips has identified that, in certain Azurion systems, one or more of these power supplies can fail due to energy peaks (surge voltages) during start or restart of the system.
When a power supply failure occurs during a start or restart, the power distribution unit does not provide the required direct current power to essential system components. As a result, the system does not successfully complete the (re-)start, imaging functionality is unavailable, and the system remains unavailable for clinical use.

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
Recall date
Identification number
RA-82876

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