CanadaThe Patient Information Centre iX clinical workstation (model/catalogue versions 4.0, 4.1, 4.2, 4.3, 4.4 and 4.5) from Philips Medical Systems Böblingen GmbH is affected. It was recalled because failure of the watchdog may leave the system frozen or in an unknown state, potentially preventing alarms from being generated or logged and causing loss of central alarming, frozen waveforms/data display, or a “No Central Mon” INOP. Contact the manufacturer for additional information.
What's being recalled
Companies: Philips Medizin Systeme Boblingen GmbH, Hewlett-Packard Strasse 2, Boblingen, Germany, 71034.
How to identify it
Affected products: Patient Information Centre iX; Lot or serial number: Not applicable.; Model or catalogue number: VERSION 4.2
Affected products: Patient Information Centre iX; Lot or serial number: Not applicable.; Model or catalogue number: VERSION 4.0
Affected products: Patient Information Centre iX; Lot or serial number: Not applicable.; Model or catalogue number: 4.5
Affected products: Patient Information Centre iX; Lot or serial number: Not applicable.; Model or catalogue number: VERSION 4.3
Affected products: Patient Information Centre iX; Lot or serial number: Not applicable.; Model or catalogue number: 4.4
Affected products: Patient Information Centre iX; Lot or serial number: Not applicable.; Model or catalogue number: VERSION 4.1
The hazard
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 the
observed 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
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)