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Terminated

ADULT/CHILD Radiotransparent Electrode, Part number C100AC-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.

FDA Recall Z-0584-2015 · Posted 2014-12-24

Recalling FirmHeart Sync, Inc.
Recall StatusTerminated
Product CodeMKJ
Date Initiated2014-11-11
Date Terminated2015-11-24
Product Quantitysold in boxes of ten electrodes: 116 boxes; 1160 units total

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

Firm 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 [email protected].

Root Cause

Device Design

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K080421HEART SYNC, MODELS C-100 AND T-100Heart Sync, LLC · 2008-02-29

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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