Recall MonitorPatient Information Centre iX
· Published by Health Canada · Official notice
Details
Products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| Patient Information Centre iX | Not applicable. | VERSION 4.2 |
| Patient Information Centre iX | Not applicable. | VERSION 4.0 |
| Patient Information Centre iX | Not applicable. | 4.5 |
| Patient Information Centre iX | Not applicable. | VERSION 4.3 |
| Patient Information Centre iX | Not applicable. | 4.4 |
| Patient Information Centre iX | Not applicable. | VERSION 4.1 |
Issue
Philips received reports that some PIC iX systems were frozen and could not be used. It was determined that failure of the watchdog may cause the system to be in an unknown state and therefore potentially prevent alarms from being generated or logged. Following the initial system error which triggers the watchdog, staff may observe unexpected system behavior while the watchdog attempts recovery. The observed behavior depends on the underlying software issue and may include:-Inability to interact with the PIC iX user interface. If real-time waveforms, numeric data,and alarms remain operational, there is no impact to bedside or central monitoring and alarming.-The user will not recognize the device issue before the hazardous situation occurs if theobserved behavior is: Loss of central alarming, Loss of, or frozen, waveforms/data display-Bedside monitors and telemetry devices could generate a "No Central Mon" INOP