Health product recall

Azurion and Allura Systems

Last updated

Summary

Product
Azurion and Allura 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 catalogue number
Azurion 7 M20 Not applicable. 722 224 722 079
Allura Xper Fd20 Or Table (Product Of Alluraclarity Family) Not applicable. 722035
Allura Xper Fd20 (Product Of Alluraclarity Family) Not applicable. 722028

Issue

Philips has identified that due to the forces applied during the movement of the c-arc of the Azurion and Allura systems, the bolts supporting the FlexMove carriage may become loose and/or break, and cracks may appear in the FlexMove carriage.
If FlexMove rail fixation bolts become loose or broken, or cracks appear in the carriage, the following issues may occur:
• transversal movements of the c-arc stop due to false collision detections because of additional friction.
• manual movement of the FlexMove carriage not possible due to added friction.
• abnormal noise during transversal movement of the c-arc.
• unstable c-arc suspension.
• fall of the c-arc assembly (1,500 kg), if all bolts in the x-axis would break/get loose.
• drop of the c-arc assembly (up to 10cm if c- arc is at one side of the rail, up to 5 cm if c-arc is in the center of the rails, and 1.5 cm if the c-arc is in the anterior/posterior position), if all bolts in the y-axis would break/get loose.

Recall start date: December 12, 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-76771

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