Reported Jun 24, 2020 · Terminated
DDU-2450 Lifeline ECG Model Numbers DDU-A2450EN DDU-E2450DE DDU-E2450EN DDU-E2450FR DDU-E2450TH Cat. No. DCF-A2460EN…
Defibtech, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Defibtech, LLC · 741 Boston Post Rd · Guilford, CT · 06437-2714
Is this the product you have?
- 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 indicated for use on victims
- of sudden cardiac arrest (SCA) who are- unconscious and unresponsive, not breathing or not breathing normally
- Lot codes and dates
- Serial numbers
94 of 94 codes
400101347400101348400101350400101351400101364400101365400101368400101371400101373400101380400101381400101382400101384400101385400101390400101392400101395400101396400101398400101399400101400400101401400101402400101403400101404400101405400101406400101407400101408400101409400101410400101411400101412400101413400101414400101415400101418400101419400101420400101421400101422400101423400101424400101425400101427400101428400101429400101430400101431400101432400101433400101434400101435400101436400101437400101438400101439400101441400101442400101444
- Serial numbers
- Amount recalled
- 860
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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