Events

Recall of HEARTSINE SAMARITAN PAD SAM 350P

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by HEARTSINE TECHNOLOGIES LTD..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    105979
  • Event Risk Class
    II
  • Event Initiated Date
    2017-06-27
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    A customer complaint from heartsine's canadian distributor rescue 7 was received questioning why a sam 350p serial number 17d00009917 was labelled with an omron raing label. (note: as well as the sam 350p heartsine also manufacture a similar device for a japanese customer omron. this japanese device is referenced as the omron hdf-3500device. the rear label specific to the omron hdf-3500 device is h045-013-013-1).

Device

HEARTSINE SAMARITAN PAD SAM 350P
  • Model / Serial
    Model Catalog: SAM 350P (Lot serial: 17D00009920); Model Catalog: SAM 350P (Lot serial: 17D00009919); Model Catalog: SAM 350P (Lot serial: 17D00009918); Model Catalog: SAM 350P (Lot serial: 17D00009917); Model Catalog: SAM 350P (Lot serial: 17D00009916); Model Catalog: SAM 350P (Lot serial: 17D00009921); Model Catalog: SAM 350P (Lot serial: 17D00009914); Model Catalog: SAM 350P (Lot serial: 17D00009913); Model Catalog: SAM 350P (Lot serial: 17D00009922); Model Catalog: SAM 350P (Lot serial: 17D00009915)
  • Product Description
    SAMARITAN PAD 350P
  • Manufacturer
    HEARTSINE TECHNOLOGIES LTD.

Manufacturer

HEARTSINE TECHNOLOGIES LTD.
  • Manufacturer Address
    BELFAST
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    HC