Health product recall

Azurion 7 M20

Last updated

Summary

Product
Azurion 7 M20
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.

722234

Issue

Philips has identified two software issues affecting Azurion R3.1 systems that may result in loss of imaging (X-ray) functionality, and/or loss of motorized movement.

Issue 1 - System remains in continuous restart mode after the start-up:
Due to a software issue, the License Manager - which verifies installed licenses and enables optional functionality in the Azurion system based on the available licenses - expands the Windows registry database at every system start or restart. Over time, the registry may grow beyond the maximum size that the License Manager can load. When this happens, the License Manager cannot start and the system will enter a continuous reboot loop. The Azurion system will not complete booting, and the message "X-ray system is booting..." remains displayed on the screen.
Issue 2 - Longitudinal position error - Applicable only to azurion systems with Poly-G3 frontal stand:
When requesting a movement of the frontal stand in longitudinal direction, the Azurion system may detect a mismatch between the expected longitudinal (set-) position and the measured (actual) position of the stand. This mismatch is caused by a glitch in the longitudinal position value provided by the position sensing potentiometer.
When the mismatch is detected, the motion power to the frontal stand is automatically cut off. The message "Some stand movements are not available" is displayed to the user.
In this situation, X-ray imaging and table movements will continue to function.
This issue can be resolved with a cold restart of the system or by restarting the geometry.

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-82951

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