Philips Patient Information Center Custom Ringtones Fail When Screen Locked
Philips Patient Information Center iX running software version 4.X may not play custom ringtones when iOS screens are locked with a passcode. Approximately 257,183 units have been distributed worldwide. No injuries have been reported.
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: FDA Class II device with no reported injuries or illnesses. The hazard is a functional limitation affecting custom ringtone notifications when device screens are locked, with available workarounds and no evidence of actual patient harm.
Plain-English summary
Philips North America is recalling the Patient Information Center iX (model numbers 866389, 866390, and 866424) running software version 4.X. Approximately 257,183 units have been distributed worldwide, including throughout the United States.
The Care Assist mobile application (version 4.1.1 and earlier) will not play custom ringtones when the iOS device screen is locked with a passcode. This may prevent delivery of audible notifications to users when the device is secured with passcode protection.
Healthcare facilities and individuals using these devices should be aware of this notification limitation. Users may address this issue by unlocking device screens, disabling passcode requirements for the application, or using default ringtones instead of custom ones. No injuries or illnesses have been reported in connection with this issue. For additional information, contact Philips North America or consult the FDA recall notice.
The recalled product
- Product
- Patient Information Center iX (PIC iX), Model Numbers 866389, 866390 (PIC iX Expand), and 866424 (PIC iX Hardware) running Software Version Number 4.X
- Manufacturer
- Philips North America
- Affected units
- 257,183
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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