Phillips IntelliVue Information Centre (PIIC) IX (2014-12-17)

Starting date:

December 17, 2014

Posting date:

December 29, 2014

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-43027

• Reason
• Affected products

Recalled Products

Phillips IntelliVue Information Centre (PIIC) IX 

Reason

A software defect that could potentially result in a drop in oxygenation (hypoxia) that is not immediately detected by the clinician. Defect involves the use of the "change bed label" feature at the information center ix. If the configuration for this item is set to "optional" and a user selects the "location" button within the "manage patient" menu and makes a change to the patient location, alarms for sp02 and/or non-invasive Blood Pressure (NBP) will become disabled without visual notification (bell with an "x") to the user. This problem only happens when the patient is monitored using a networked Intellivue TRX Telemetry M4841/TRX 4851a patient worn device (PWD).

Affected products