Health product recall

Philips Allura and Azurion

Last updated

Summary

Product
Philips Allura and Azurion
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 catalogue number
Allura Xper Fd10 (Product Of Alluraclarity Family) All lots. 722026
Allura Xper Fd20 Or Table (Part Of Alluraclarity Family) All lots. 722035
Vitros Chemistry Products System - Eco2 Slides (Carbon Dioxide) All lots. 722 227
Integris H5000c Cardiology Imaging System All lots. 722016
Azurion 5 M20 All lots. 722 228
Allura Xper Fd10 All lots. 001443
Allura Xper Fd20/15 All lots. 722058
Allura Xper Fd10 Or Table (Product Of Alluraclarity Family) All lots. 722033
Allura Xper Fd20 (Product Of Alluraclarity Family) All lots. 722028
Allura Xperfd20/20 (Product Of Alluraclarity Family) All lots. 722038
Azurion 7 M12 All lots. 722 223 722 078
Azurion 7 M20 All lots. 722 224 722 079

Issue

Philips has identified a potential safety issue with the Philips Allura and Azurion product families having monoplane fixed ceiling mounted systems. The ceiling mounted l-arm contains a rotation cover that may potentially be susceptible to falling if a collision between the l-arm and other hospital equipment (i.e., an operating light) were to occur. Although the cover is retained by a safety chain, if a collision were to occur the chain may also detach resulting in the cover falling on the patient, user, or bystander.

Recall start date: November 3, 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-74640