Z-0585-2015Class I

ADULT Radiotranslucent Electrode, Part number T100LO-PHILIPS, Rx ONLY, For use with Philips HeartStart AED...

Name: Z-0585-2015 ADULT Radiotranslucent Electrode, Part number T100LO-PHILIPS, Rx ONLY, For use with Philips HeartStart AED...
Creator: Heart Sync, Inc.
Published: 2014-11-11
License: https://open.fda.gov/license/

Graphic Controls Acquisition Corp.dba Nissha Medical Technologies / initiated 2014-11-11 / Terminated / root cause: design

FDA source

Heart Sync, Inc. began a recall of ADULT Radiotranslucent Electrode, Part number T100LO-PHILIPS, Rx ONLY, For use with Philips HeartStart AED "Comparable to Philips Medical HeartStart Electrodes... on 2014-11-11. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0585-2015
Classification: Class I
Status: Terminated
Initiated: 2014-11-11
Posted: 2014-12-24
Terminated: 2015-11-24
Recalling firm: Graphic Controls Acquisition Corp.dba Nissha Medical Technologies
Product: ADULT Radiotranslucent Electrode, Part number T100LO-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.
Product code: MKJ Automated External Defibrillators (Non-Wearable)
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 tag: design
FDA root cause: 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 [email protected].
Quantity in commerce: sold in boxes of ten electrodes: 1791.3 boxes; 17913 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.
Product codes and lots: All Lots. Catalog / Part Number T100LO-PHILIPS

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0585-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0583-2015	Class I	Terminated	Voluntary: Firm initiated	2014-12-31	2014-12-23
Z-0584-2015	Class I	Terminated	Voluntary: Firm initiated	2014-12-31	2014-12-23
Z-0585-2015	Class I	Terminated	Voluntary: Firm initiated	2014-12-31	2014-12-23
Z-0586-2015	Class I	Terminated	Voluntary: Firm initiated	2014-12-31	2014-12-23
Z-0587-2015	Class I	Terminated	Voluntary: Firm initiated	2014-12-31	2014-12-23

Product code MKJ

K080421Class IIIHeart Sync, Models C-100 and T-100Heart Sync, LLC / cleared 2008-02-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)