The Recall Desk
ModerateFDA (Devices)·Z-1386-2024·Announced 2024-04-03

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.

What this means for you

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
Hazard
  • notification-failure
  • alert-missed

Distribution

Distributed nationwide across the United States.