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Health Canada Medical devices

Patient Information Center iX

Issued March 14, 2024
Issue
It was found that the care assist mobile application (version 4.1.1 and earlier) would not play custom ringtones when ios device screens were locked with a passcode. The issue occurred on devices running IOS 15, 16 and 17 as well as multiple versions of iPhones. The care assist mobile application is not intended to replace the patient's primary alarming system. If users rely on the care assist application as their primary event notification alarming system, the failure of custom ringtones could result in a delay in treatment for patients experiencing a change in clinical condition. Recall Start Date: March 6, 2024
Hazard description
Performance
Product
Product name
Patient Information Center iX
Reference
ID
RA-75241