Health product recall

Patient Information Centre iX

Last updated

Summary

Product
Patient Information Centre iX
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information.

Audience
Healthcare

Affected 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 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

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - General hospital and personal use
Companies

Philips Medizin Systeme Boblingen GmbH

Hewlett-Packard Strasse 2, Boblingen, Germany, 71034

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Recall date
Identification number
RA-82511

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