| Class 1 Device Recall Heart Sync, Inc. | |
Date Initiated by Firm | November 11, 2014 |
Date Posted | December 24, 2014 |
Recall Status1 |
Terminated 3 on November 24, 2015 |
Recall Number | Z-0587-2015 |
Recall Event ID |
69875 |
510(K)Number | K080421 |
Product Classification |
Automated external defibrillators (non-wearable) - Product Code MKJ
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Product | ADULT/CHILD Radiotranslucent Electrode, Part number T100AC-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 T100AC-PHILIPS |
Recalling Firm/ Manufacturer |
Heart Sync, Inc. 5643 Plymouth Rd Ann Arbor MI 48105-9586
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For Additional Information Contact | Jahan Azizi 734-213-5530 |
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: 209 boxes: 2090 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 |
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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.
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510(K) Database | 510(K)s with Product Code = MKJ
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