{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "132028", "product_res_number": "Z-0587-2015", "event_date_initiated": "2014-11-11", "event_date_posted": "2014-12-24", "recall_status": "Terminated", "event_date_terminated": "2015-11-24", "res_event_number": "69875", "product_code": "MKJ", "k_numbers": [ "K080421" ], "product_description": "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_info": "All Lots.  Catalog / Part Number T100AC-PHILIPS", "firm_fei_number": "1317188", "recalling_firm": "Heart Sync, Inc.", "address_1": "5643 Plymouth Rd", "city": "Ann Arbor", "state": "MI", "postal_code": "48105-9586", "additional_info_contact": "Jahan Azizi\n734-213-5530", "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", "root_cause_description": "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. \n\nFor 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.", "product_quantity": "sold in boxes of ten electrodes: 209 boxes: 2090 units total", "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.", "openfda": { "k_number": [ "K032439", "K971148", "K896919", "K992543", "K860676", "K983393", "K003565", "K040256", "K091561", "K031187", "K853564", "K030898", "K011144", "K103567", "K953204", "K955628", "K120406", "K111594", "K012766", "K002232", "K133484", "K150055", "K120536", 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