CLASS II Device recall · Reported 24 Jun 2020 · FDA Enforcement Report
DDU-2450 Lifeline ECG recalled by Defibtech
Defibtech is recalling DDU-2450 Lifeline ECG, distributed nationwide in the US. The recall was initiated on 27 Apr 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2394-2020
- FDA event ID
- 85702
- Recalling firm
- Defibtech, Guilford, CT
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 27 Apr 2020
- FDA classified
- 17 Jun 2020
- Reported
- 24 Jun 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Device Malfunction
- Device type
- Pacemakers & Defibrillators
Timeline
| 27 Apr 2020 | Recall initiated by company | |
| 17 Jun 2020 | Classified by FDA | +51 days |
| 24 Jun 2020 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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.
Where it was distributed
Worldwide distribution - US Nationwide distribution and the countries of Australia, Canada, France, Malaysia, Mauritius, Netherlands, Thailand, United Arab Emirates.
Questions about this recall
Is DDU-2450 Lifeline ECG recalled?
Yes. Defibtech recalled DDU-2450 Lifeline ECG on 27 Apr 2020. The recall is Class II and its status is Terminated. Recall number Z-2394-2020.
Why was it 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.
Which lots are affected?
Serial numbers: 400101347 400101348 400101350 400101351 400101364 400101365 400101368 400101371 400101373 400101380 400101381 400101382 400101384 400101385 400101390 400101392 400101395 400101396 400101398 400101399 400101400 400101401 400101402 400101403 400101404 400101405 400101406 400101407 400101408 400101409 400101410 400101411 400101412 400101413 400101414 400101415 400101418 400101419 400101420 400101421 400101422 400101423 400101424 400101425 400101427 400101428 400101429 400101430 400101431 400101432 400101433 400101434 400101435 400101436 400101437 400101438 400101439 400101441 400101442 400101444 400101446 400101447 400101448 400101449 400101451 400101452 400101453 400101454 400101455 400101456 400101457 400101458 400101459 400101460 400101461 400101462 400101463 400101464 400101465 400101466 400101467 400101468 400101469 400101470 400101471 400101472 400101473 400101474 400101475 400101477 400101478 400101480 400101483 400101486
Where was it sold?
Worldwide distribution - US Nationwide distribution and the countries of Australia, Canada, France, Malaysia, Mauritius, Netherlands, Thailand, United Arab Emirates.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Defibtech
All 14| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Automated External Defibrillators recalled by Defibtech | Defibtech | Other | Nationwide |
| Device | CLASS II | Automated External Defibrillators recalled by Defibtech | Defibtech | Other | CT |
| Device | CLASS II | Automated External Defibrillators recalled by Defibtech | Defibtech | Other | Nationwide |
| Device | CLASS II | Automated External Defibrillators recalled by Defibtech | Defibtech | Other | Nationwide |
| Device | CLASS II | Semi-Automated External Defibrillators recalled by Defibtech | Defibtech | Other | Nationwide |
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| Device | CLASS II | Medline convenience kits: Acl Pack DYNJ64161C Arthroscopy recalled | Medline Industries | Foreign Material | Nationwide |
| Device | CLASS II | Medline convenience kits: Bib AV Fistula Pack DYNJ58304B recalled | Medline Industries | Device Malfunction | Nationwide |