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

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  Reason
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  Affected products

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