Events

Recall of Device Recall Heart Sync, Inc.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Heart Sync, 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
    69875
  • Event Risk Class
    Class 1
  • Event Number
    Z-0583-2015
  • Event Initiated Date
    2014-11-11
  • Event Date Posted
    2014-12-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-11-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131854
  • 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
    Heart sync multi-function defibrillation electrodes will not connect with philips fr3 or frx aed units. the frx aed unit requires the pads to be pre-connected, and will issue a continuous alarm chirp to alert the user that the proper pads are not connected to the unit prior to use. the fr3, however, does not require pre-connection and the user may not discover the incompatibility issue until the.
  • Action
    The firm, HeartSync, sent an "Voluntary Field Safety Alert for Heart Sync Multi-function Defibrillator Electrodes" notice dated 11/11/2014 to customers via email notifying them of the incompatibility with the Philips FR3 and FRX AEDs and requesting response to the notice. On 12/1/2014 (dated 11/26/2014) Heart Sync issued a Voluntary Device Correction via Press Release. The Press Release included a description of the reason for the recall, affected product, and instruction that the Philips FR3 and FRx AED units should only be used with electrodes specified in the (Philips) equipment manuals. For further information or to report a problem, please contact Heart Sync at 734-213-5530, 24 hours a day, 7 days a week, ,or email at Jahana@heartsync.net.

Device

Device Recall Heart Sync, Inc.
  • Model / Serial
    All Lots.  Catalog / Part Number C100-PHILIPS
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (Nationwide) in the states of NM, VT, MN, IL, MO, OH, MI, OR, ND, KY, PA, TX, WA, FL, NE, AR, VA, DE, GA, NY, CA, TN, AZ, RI, MA, and PR; and countries of: Thailand and South Korea.
  • Product Description
    ADULT Radiotransparent Electrode, Part number C100-PHILIPS, Rx ONLY, For use with Philips HeartStart AED "Comparable to Philips Medical HeartStart Electrodes Plug Style Connector", Intended for use during defibrillation, cardioversion, pacing, and ECG monitoring, Single use.
  • Manufacturer
    Heart Sync, Inc.

Manufacturer

Heart Sync, Inc.
  • Manufacturer Address
    Heart Sync, Inc., 5643 Plymouth Rd, Ann Arbor MI 48105-9586
  • Manufacturer Parent Company (2017)
    Heart Sync Inc
  • Source
    USFDA