The Recall Desk

FDA (Devices) recall action 85702

Defibtech, LLC recalled 3 products on 2020-06-24

The FDA (Devices) publishes a recall like this one as 3 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 3 pages.

Products
3
Announced
2020-06-24
Critical
0
Units
2,580

Why these products were recalled

A component issue may cause the AED to abort a shock delivery or reset unexpectedly, which may cause an affected device to fail to delivery shock, and/or to fail to deliver shock in range.

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

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–3 of 3

  • HighFDA (Devices)··2020-06-24

    Defibtech DDU-2300 AED Recalled for Potential Shock Delivery Failure

    Defibtech is recalling 860 DDU-2300 AEDs because a component issue may cause the device to abort or fail to deliver a shock.

    Product
    DDU-2300 Lifeline/ReviveR View, Model Numbers DDU-C2300EN, DDU-C2300CA, DDU-A2300EN, DDU-E2300EN Catalog Numbers CCD-A1006RX CCD-A1013EN CCD-A1015EN DCF-A2310EN DCF-A2310RX DCF-A2313EN DCF-C2310CA DCF-C2310EN DCF-E2310CA DCF-E2310EN UDI 00815098020201…
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2020-06-24

    Defibtech Recalls 860 Lifeline PRO AEDs Due to Shock Delivery Failure

    Defibtech is recalling 860 Lifeline PRO AEDs because a component issue may cause the device to abort or fail to deliver a shock.

    Product
    DDU-2400EN Lifeline PRO, UDI 00815098020270 - Product Usage: Automated External Defibrillators (AED) are indicated for use on victims of sudden cardiac arrest (SCA) who are: - unconscious and unresponsive, not breathing or not breathing normally.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2020-06-24

    Defibtech Lifeline ECG AEDs Recalled for Potential Shock Delivery Failure

    Defibtech is recalling 860 Lifeline ECG Automated External Defibrillators because a component issue may cause the device to abort or reset, potentially failing to deliver a shock.

    Product
    DDU-2450 Lifeline ECG Model Numbers DDU-A2450EN DDU-E2450DE DDU-E2450EN DDU-E2450FR DDU-E2450TH Cat. No. DCF-A2460EN DCF-A2463EN DCF-E2460DE DCF-E2460EN DCF-E2460FR DCF-E2460TH UDI 00815098020287, 00815098020317 Automated External Defibrillators (AED) are…
    Category
    Distribution
    0 states