ITS4850A Intellivue Telemetry System (2020-02-28)

Starting date:

February 28, 2020

Posting date:

March 13, 2020

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-72589

Last updated: 2020-03-13

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  Reason
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  Affected products

Affected Products

ITS4850A Intellivue Telemetry System

Reason

The ECG signal from patients being monitored using a Philips TRx4851A Telemetry Transceiver may not be properly analyzed when the transceiver is used with a Philips Patient Information Center iX Release C.02.00, C.02.02, C.02.03 (all released versions of C.02, collectively referred to as ‘C.02.xx’) or C.03.01. If this occurs, the Information Center will not display a heart rate or generate, display or annunciate any heart rate or arrhythmia alarms.

Alarming based on pulse oximetry (SpO2) signals are unaffected by this issue.

Affected products