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Health product recall

ITS4850A Intellivue Telemetry System - Moinitor (2014-05-20)

Starting date:
May 20, 2014
Posting date:
June 12, 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-39997

Recalled products

  1. ITS4850A  Intellivue Telemetry System - Moinitor 

Reason

Philips has become aware that IntelliVue MX40 System (part numbers 865350, 865351, 865352) with software revisions B.00 or B.01 may not resume alarming when the alarms are paused and the pause timer ends. This issue will only occur when Teh MX40 device is in monitor mode connected to a Philips IntelliVue Information Center iX (PIIC iX) that is not in a specific default configuration.

Affected products

A. ITS4850A  Intellivue Telemetry System - Moinitor

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number
  • MX40
Companies
Manufacturer
Philips Medical Systems
3000 Minuteman Road
Andover
01810
Massachusetts
UNITED STATES