Starting from 1 January 2022, active safety alerts related to medical devices listed under MDACS are listed below. For safety alerts before 1 January 2022, please refer to archive.
The Australian Therapeutic Goods Administration (TGA) has posted a medical device safety alert concerning Philips Medical Systems PIC iX Version 4.X and CareEvent Version C.03.X [HKMD No.: 150026, 210175].
According to the TGA, the manfacturer has become aware of a potential safety issue with the Care Assist application background alerts for iOS devices (e.g iPhone, iPad).
It has been discovered that background notifications for the Care Assist application fail to send from PIC iX Event Notification and CareEvent under certain conditions. This failure is applicable to Apple iOS devices only.
Specifically, when a user places the Care Assist application into the background on an iOS device by opening a different application or locking the device, etc., the user is registered as being logged off from the device. Under this condition, push notifications are no longer sent to the user. If the Care Assist application is in the foreground (i.e., actively open on the user device), the events are correctly sent to the connected iOS device.
For further information, please visit https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2023-RN-01043-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 4 Dec 2023