Heartsine Samaritan PAD (2020-01-13)

Starting date:

January 13, 2020

Posting date:

January 31, 2020

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-72231

Last updated: 2020-01-31

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  Reason
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  Affected products

Affected Products

Heartsine Samaritan PAD

Reason

HeartSine Technologies, now part of Stryker, is conducting a Field Action for specific HeartSine samaritan PAD 450P devices that have been shipped into countries where registration approval has not been received. HeartSine Technologies/Stryker has become aware [during a review of device tracking data Spetember 2019] that thirty SAM 450P devices [sold to customers in the USA] are now listed in Canada as the end user location. The SAM 450P device is not registered for sale in Canada.

Affected products