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U.S. Department of Health and Human Services

Class 1 Device Recall Heart Sync, Inc.

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  Class 1 Device Recall Heart Sync, Inc. see related information
Date Initiated by Firm November 11, 2014
Date Posted December 24, 2014
Recall Status1 Terminated 3 on November 24, 2015
Recall Number Z-0583-2015
Recall Event ID 69875
510(K)Number K080421  
Product Classification Automated external defibrillators (non-wearable) - Product Code MKJ
Product 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.
Code Information All Lots.  Catalog / Part Number C100-PHILIPS
Recalling Firm/
Heart Sync, Inc.
5643 Plymouth Rd
Ann Arbor MI 48105-9586
For Additional Information Contact Jahan Azizi
Manufacturer Reason
for Recall
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
FDA Determined
Cause 2
Device Design
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.
Quantity in Commerce sold in boxes of ten electrodes: 4663.8 boxes; 46638 units total
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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MKJ and Original Applicant = HEART SYNC LLC