openFDA Device Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall
event_date_initiated coverage
June 01, 1997–June 30, 2026
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
device · product 1 of 5
ADULT Radiotransparent Electrode, Part number C100-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.
sold in boxes of ten electrodes: 4663.8 boxes; 46638 units total
App-derived interpretation
Unknownreason.no_named_rule · v1.0.0
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
These labels are deterministic app interpretations, not FDA categories.
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
Code information
All Lots. Catalog / Part Number C100-PHILIPS
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.
device · product 2 of 5
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.
sold in boxes of ten electrodes: 116 boxes; 1160 units total
App-derived interpretation
Unknownreason.no_named_rule · v1.0.0
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
These labels are deterministic app interpretations, not FDA categories.
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
Code information
All Lots. Catalog / Part Number C100AC-PHILIPS
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.
device · product 3 of 5
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.
sold in boxes of ten electrodes: 1791.3 boxes; 17913 units total
App-derived interpretation
Unknownreason.no_named_rule · v1.0.0
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
These labels are deterministic app interpretations, not FDA categories.
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
Code information
All Lots. Catalog / Part Number T100LO-PHILIPS
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.
device · product 4 of 5
ADULT Radiotranslucent Electrode, Part number T100-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.
sold in boxes of ten electrodes: 4692.9 boxes; 46929 units total
App-derived interpretation
Unknownreason.no_named_rule · v1.0.0
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
These labels are deterministic app interpretations, not FDA categories.
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
Code information
All Lots. Catalog / Part Number T100-PHILIPS
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.
device · product 5 of 5
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.
sold in boxes of ten electrodes: 209 boxes: 2090 units total
App-derived interpretation
Unknownreason.no_named_rule · v1.0.0
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
These labels are deterministic app interpretations, not FDA categories.
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
Code information
All Lots. Catalog / Part Number T100AC-PHILIPS
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.
