Health product recall

Azurion 3 and 7

Last updated

Summary

Product
Azurion 3 and 7
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

Azurion 3 M15

Not applicable.

722 064

Azurion 7 M12

Not applicable.

722 078

Azurion 3 M12

Not applicable.

722 063

Azurion 7 B20

Not applicable.

722 068

Azurion 7 M20

Not applicable.

722 079

Azurion 7 B12

Not applicable.

722 067

Issue

Philips has identified two issues in software version R1.X of the Philips Azurion system that may affect:



a) Management of the system log trace files: The mechanism that is present in the system to manage the number and size of the system log trace files does not function properly, as a result of which the log trace files related to remote connection logging may occupy the full hard disk capacity of the Philips Azurion R1.X system. When the full disk capacity is reached, imaging (X-ray) functionality will cease to be available without an advance warning to the user. A restart of the system will not resolve the issue.

Note: This issue only impacts the Philips Azurion R1.X systems that are currently connected to Philips remote service or that were connected in the past.



b) Time to perform a cold restart: A cold restart of the Philips Azurion R1.X system may take up to 6 minutes as stated in the instructions for use of the system (section 4.2). This time includes the time required for the system to shut down and the system to start up. However, there are instances where the shutdown of the system may be prolonged (with up to 4 minutes) resulting in the cold restart taking longer (up to 10 minutes in total).

Recall Start Date: July 17, 2024

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-75918

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