LIFEPAK 15 Monitor/Defibrillator (2019-01-29)

Starting date:
January 29, 2019
Posting date:
February 12, 2019
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type I
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-69020

Affected Products

LIFEPAK 15 Monitor/Defibrillator

Reason

Stryker has become aware [via customer complaint] that certain LIFEPAK 15 Monitor/Defibrillators were reported to experience a lock-up condition after a defibrillation shock was delivered. This condition is defined as a blank monitor display with LED lights on, indicating power to the device, but no response in the keypad and device functions. A device in this condition has the potential to delay delivery of therapy, and this delay in therapy has the potential to result in serious injury or death.

Affected products

LIFEPAK 15 Monitor/Defibrillator

Lot or serial number

More than 100 numbers, contact manufacturer.

Model or catalog number

99577-000837
99577-000839
99577-001255
99577-001256
99577-001262
99577-XXXXXX

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