CareEvent Event Management System notification failure on locked iOS devices
The CareEvent Event Management System's Care Assist mobile application fails to play custom ringtones when iOS device screens are locked with a passcode. This may result in missed alerts or notifications.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. While the feature defect could affect alert delivery, the hazard is limited to a notification feature rather than core safety functionality.
Plain-English summary
Philips North America has recalled the CareEvent Event Management System (Models 866435 and 866436, Software Version C.03.X) due to a defect in the Care Assist mobile application (version 4.1.1 and earlier). The application fails to play custom ringtones when iOS device screens are locked with a passcode.
When an iOS device is locked with a passcode, the Care Assist application will not produce audible alerts through custom ringtones. This prevents users from receiving notifications through these custom sounds while their device is locked.
Approximately 2,323 units of the affected CareEvent Event Management System have been distributed worldwide, including throughout the United States. The defect applies to Care Assist mobile application version 4.1.1 and earlier.
Users with affected devices should contact Philips North America for additional information and guidance regarding this recall and potential remediation options.
The recalled product
- Product
- CareEvent Event Management System, Model Numbers 866435 and 866436 (CareEvent Upgrade), Software Version Number C.03.X
- Manufacturer
- Philips North America
- Affected units
- 2,323
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI: (01)00884838099128(10)C.03.00
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Philips North America under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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