Events

Recall of Device Recall AliveECG App Version 2.1.2 used with AliveCor Heart Monitor

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

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
    70363
  • Event Risk Class
    Class 3
  • Event Number
    Z-1125-2015
  • Event Initiated Date
    2015-01-09
  • Event Date Posted
    2015-02-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-02-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=133315
  • 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
    Transmitters and receivers, electrocardiograph, telephone - Product Code DXH
  • Reason
    Alive ecg app version 2.1.2 (intended to be used with the alivecor heart monitor) crashed upon use of the application.
  • Action
    AliveCor posted information on their website, Facebook Page and Twitter to alert users of the issue.

Device

Device Recall AliveECG App Version 2.1.2 used with AliveCor Heart Monitor
  • Model / Serial
    v2.1.2
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Downloaded by Apple users - locations not shared by Apple.
  • Product Description
    Alive ECG App 2.1.2 ( a medical device application for the Apple iOS operating system, intended to be used with the AliveCor Heart Monitor. The AliveCor Heart Monitor is intended to record, store and transfer single-channel electrocardiogram (ECG) rhythms. The AliveCor Heart Monitor also displays ECG rhythms and detects the presence of atrial fibrillation and normal sinus rhythm (when prescribed or used under the care of a physician).
  • Manufacturer
    Alivecor SFO

Manufacturer

Alivecor SFO
  • Manufacturer Address
    Alivecor SFO, 30 Maiden Ln, Suite 600, San Francisco CA 94108-5429
  • Manufacturer Parent Company (2017)
    AliveCor Inc.
  • Source
    USFDA