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Health product recall

Lifepak 15 Monitor/Defibrillator

Starting date:
December 23, 2016
Posting date:
January 25, 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-61962

Reason

Physio-Control has become aware of an issue where the end tidal CO2 (ETCO2) reading can intermittently show a value of "xxx" after start-up or during device operation. There may be solid or dashed lines present on the device display in the place of an ETCO2 waveform and the service led will be illuminated.  In this situation the ETCO2 monitoring functionality will no longer be available.

Affected products

Lifepak 15 Monitor/Defibrillator

Lot or serial number

More than 10 numbers, contact manufacturer

Model or catalog number

  • 99577-xxxxxx

Companies

Manufacturer
Physio-Control Inc.
11811 Willows Road North East
Redmond
98052
Washington
UNITED STATES