Events

Recall of Device Recall SAMARITAN AED DEFIBRILLATORS

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
    31212
  • Event Risk Class
    Class 1
  • Event Number
    Z-0641-05
  • Event Initiated Date
    2005-02-14
  • Event Date Posted
    2005-03-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-06-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=37385
  • 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 defibrillator - Product Code MKJ
  • Reason
    The affected automatic external defibrillators (aed) annouce a fault warning and shut themselves off before a shock can be delivered to the patient. this is reportedly due to slow capacitor charging rates which are interpreted by the aed software as a fault condition.
  • Action
    Recall was initiated by telephone 2/14/2005 with follow-up fax, email or postal mailing using one of several customized letters for distributors or customers. Customers will be sent an upgrade kit by overnite mail and forms to confirm upgrade.

Device

Device Recall SAMARITAN AED DEFIBRILLATORS
  • Model / Serial
    Heartsine Samaritan AED Defibrillators - Models: SAM 001, SAM 002, SAM 003. Serial numbers within range of 1270 - 2324 (not all are affected).
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Nationwide to distributors and user facilities. Also to Argentina, Austria, Belgium, Finland, France, Germany, Hong Kong, Ireland, Israel, Italy, Japan, Kuwait, Netherlands, Portugal, Puerto Rico, Singapore, Spain, Switzerland, Thailand, United Kingdom.
  • Product Description
    Heartsine Samaritan AED Defibrillators - Models: SAM 001, SAM 002, SAM 003. Serial numbers within range of 1270 - 2324 (not all are affected).
  • 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