Events

Recall of HeartSine Samaritan AED

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Heartsine Technologies Inc.

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
    31445
  • Event Risk Class
    Class 2
  • Event Number
    Z-1046-05
  • Event Initiated Date
    2005-10-05
  • Event Date Posted
    2005-07-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-02-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=37884
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Automated External Defibrillators (Non-Wearable) - Product Code MKJ
  • Reason
    Immediately after battery installation the devices announce a low battery fault warning and shut themselves off, or the service indicator icon starts blinking indicating a fault condition.
  • Action
    AED software revision 1.0.20 and higher incorporate software enhancements to make the AED more forgiving for extreme variations in user technique. Firm will provide distributors with field correction notice dated 10/5/05. Customers to be notified by mid-October 2005.

Device

HeartSine Samaritan AED
  • Model / Serial
    Serial numbers within range of 0000101 and 00003986
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Nationwide, Puerto Rico, Argentina, Australia, Austria, Belgium, Denmark, Ecuador, Finland, France, Germany, Greece, Hong Kong, Iceland, India, Iran, Ireland, Israel, Italy, Japan, Netherlands, Pakistan, Phillipines, Poland, Portugal, Saudi Arabia, Singapore, South Africa, Spain, Switzerland, Thailand, UK
  • Product Description
    HeartSine Samaritan AED Defibrillators Models: SAM 001, SAM 002, SAM 003.
  • Manufacturer
    Heartsine Technologies Inc

Manufacturer

Heartsine Technologies Inc
  • Manufacturer Address
    Heartsine Technologies Inc, 940 Calle Amanecer Ste E, San Clemente CA 92673-6218
  • Source
    USFDA