ADULT Radiotranslucent Electrode, Part number T100-PHILIPS, Rx ONLY, For use with Philips HeartStart AED "Comparable to

FDA device recall Z-0586-2015 · posted 2014-12-24 · Terminated

Recall details

Recalling firm

Heart Sync, Inc.

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

Action taken

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.

Root cause

Device Design

Status

Terminated

Product code

MKJ

Quantity affected

sold in boxes of ten electrodes: 4692.9 boxes; 46929 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 So

Date initiated

2014-11-11

Date posted

2014-12-24

Date terminated

2015-11-24

Location

Ann Arbor, MI

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