| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00183-1 |
| Product Name/Description |
Philips CareEvent & Patient Information Center iX (PIC iX)
Model: Patient Information Center iX
Product code: 866389
UDI: (01)00884838104594(10) 4.0.1, (01)00884838104594(10) 4.0.2, (01)00884838112070(10) 4.1.0, (01)00884838112070(10) 4.1.1, (01)00884838121782(10) 4.2.0, (01)00884838121782(10) 4.2.1, (01)00884838121782(10) 4.2.2
Model: CareEvent
Product code: 866435
UDI: (01)00884838099128(10) C.03.XX
ARTG 384159
(Philips Electronics Australia Ltd - Patient monitor, central unit) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
8/03/2024 |
| Responsible Entity |
|
| Reason/Issue |
It was found that the Care Assist mobile application (version 4.1.1 and earlier) would not play custom ringtones when iOS device screens were locked with a passcode. The issue occurred on devices running iOS 15, 16 and 17 as well as multiple versions of iPhones.
The Care Assist mobile application is not intended to replace the patient’s primary alarming system. If users rely on the Care Assist application as their primary event notification alarming system, the failure of custom ringtones could result in a delay in treatment for patients experiencing a change in clinical condition. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Customers should:
1 Note that the Care Assist mobile application should be used in conjunction with other monitoring devices such as a bedside monitor, telemetry monitor and central monitor which continue to provide visual and audible alarm information to inform clinicians of changes in patient status.
2. Update their iOS devices to version 4.1.2 of Care Assist mobile application or greater to eliminate the software defect affecting the annunciation of custom ringtones.
NB: The Care Assist version 4.1.2 mobile application will be made available immediately in the Apple App Store. |
| Contact Information |
1800 251 400 - Philips Service Delivery Team |