Health product recall

Philips Azurion System

Last updated

Summary

Product
Philips Azurion System
Issue
Medical devices - Performance issue
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 7 B12

151
188

722 067

Azurion 7 B20

149
296

722 226
722 068

Azurion 7 M20

More than 10 numbers, contact manufacturer.

722 224
722 079

Azurion 7 M12

More than 10 numbers, contact manufacturer.

722 223
722 078

Issue

Philips Azurion System may unexpectedly lose X-ray functionality. Due to a software issue, a mechanism that is present in the system to manage the number and size of log trace files does not function properly. Without this mechanism, the log trace files created by the system (e.g., at start, during use) may occupy the full disk capacity of the Philips Azurion system. When the full disk capacity is reached, X-ray functionality will cease to be available without an advance warning to the user.

Recall start date: March 23, 2023

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-73421

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