FDA (Devices) recall action 93638
The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.
Push notifications may fail to send to the user under certain conditions. This could potentially result in patient harm due to delay in detection of a change in patient condition.
The agency’s own wording, quoted from the enforcement report.
The CareEvent patient monitoring device may fail to send push notifications, potentially delaying detection of patient condition changes.
Philips Patient Information Center iX devices may fail to send push notifications under certain conditions, potentially delaying detection of patient condition changes. A total of 814 units have been recalled worldwide.