Health product recall

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

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

ITS4850A Intellivue Telemetry System

Lot or serial number

Not applicable.

Model or catalog number

TRX4851A

Companies
Manufacturer
Philips Medical Systems
3000 Minuteman Road
Andover
01810
Massachusetts
UNITED STATES