The Recall Desk

FDA (Devices) recall action 69875

Heart Sync, Inc. recalled 5 products on 2014-12-31

The FDA (Devices) publishes a recall like this one as 5 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 5 pages.

Products
5
Announced
2014-12-31
Critical
0
Units
—

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

States named across these recalls

1–5 of 5

  • HighFDA (Devices)··2014-12-31

    Heart Sync Defibrillation Electrodes Recalled for Incompatibility with Philips AEDs

    Heart Sync, Inc. is recalling Adult Radiotranslucent Electrodes because they do not connect with Philips FR3 or FRx AED units, potentially preventing defibrillation.

    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.
    Category
    Distribution
    26 states
  • SevereFDA (Devices)··2014-12-31

    Heart Sync Electrodes Recalled for Incompatibility with Philips AEDs

    Heart Sync, Inc. is recalling Adult Radiotransparent Electrodes that fail to connect with Philips FR3 or FRx AED units, potentially preventing defibrillation.

    Product
    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.
    Category
    Distribution
    26 states
  • HighFDA (Devices)··2014-12-31

    Heart Sync Defibrillation Electrodes Recalled for Incompatibility with Philips AEDs

    Heart Sync, Inc. is recalling Adult/Child Radiotransparent Electrodes because they do not connect with Philips FR3 or FRx AED units, potentially preventing defibrillation.

    Product
    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
    Category
    Distribution
    26 states
  • HighFDA (Devices)··2014-12-31

    Heart Sync Electrodes Recalled for Incompatibility with Philips AEDs

    Heart Sync, Inc. is recalling multi-function defibrillation electrodes that do not connect with Philips FR3 or FRx AED units, potentially preventing proper device operation.

    Product
    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 u
    Category
    Distribution
    26 states
  • HighFDA (Devices)··2014-12-31

    Heart Sync Multi-function Defibrillation Electrodes Recalled for Incompatibility

    Heart Sync, Inc. is recalling multi-function defibrillation electrodes that do not connect with Philips FR3 or FRx AED units, potentially preventing proper use.

    Product
    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.
    Category
    Distribution
    26 states