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Health product recall

ITS4850A Intellivue Telemetry System-Main Unit

Starting date:
March 6, 2017
Posting date:
March 31, 2017
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-62852

Reason

Philips has recently discovered that under specific 802.11 network conditions, a partial re-association of the MX40 WLAN monitor to a compatible central monitoring system ("information center") is possible. In this state, although the information center provides a visible and audible "no data tele" INOP alert, the MX40 WLAN itself enters telemetry mode, i.e., its screen turns off in one minute and local alarming is disabled.

Affected products

ITS4850A Intellivue Telemetry System-Main Unit

Lot or serial number

More than 100 numbers, contact manufacturer

Model or catalog number

ITS4850A

Companies

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