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ITS4850A INTELLIVUE TELEMETRY SYSTEM-MONITOR
- Starting date:
- September 19, 2016
- 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-60446
Affected Products
Reason
When the local configuration setting 'alarms on' is modified from its factory default, in certain software revisions the Philips Intellivue MX40 patient wearable monitor will disable generation and delivery of electrocardiogram (ECG) alarms to the Philips Intellivue Information Center IX (PIIC IX) without visual indication on the PIIC IX that the ECG alarms have been disabled. This could lead to a delay in treatment.
Affected products
ITS4850A INTELLIVUE TELEMETRY SYSTEM-MONITOR
Lot or serial number
Not Applicable
Model or catalog number
MX40
Companies
- Manufacturer
-
Philips Medical Systems
3000 Minuteman Road
Andover
01810
Massachusetts
UNITED STATES