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Health Canada Medical devices

Philips Allura and Azurion

Issued November 24, 2023
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
Hazard description
Performance
Product
Product name
Philips Allura and Azurion
Reference
ID
RA-74640