Z-2394-2020Class II

DDU-2450 Lifeline ECG Model Numbers DDU-A2450EN DDU-E2450DE DDU-E2450EN DDU-E2450FR DDU-E2450TH Cat. No...

Name: Z-2394-2020 DDU-2450 Lifeline ECG Model Numbers DDU-A2450EN DDU-E2450DE DDU-E2450EN DDU-E2450FR DDU-E2450TH Cat. No...
Creator: Defibtech, LLC
Published: 2020-04-27
License: https://open.fda.gov/license/

Defibtech LLC / initiated 2020-04-27 / Terminated / root cause: design

FDA source

Defibtech, LLC began a recall of 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... on 2020-04-27. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2394-2020
Classification: Class II
Status: Terminated
Initiated: 2020-04-27
Posted: 2020-06-17
Terminated: 2021-01-08
Recalling firm: Defibtech LLC
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 indicated for use on victims of sudden cardiac arrest (SCA) who are: - unconscious and unresponsive, not breathing or not breathing normally.
Product code: MKJ Automated External Defibrillators (Non-Wearable)
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.
Root cause tag: design
FDA root cause: Component design/selection
Action: The firm contacted affected customers via email and mailed letter on April 27, 2020. Distributors were asked to forward letters to end users. Customers were informed that affected products may abort a shock delivery or reset unexpectedly. Customers were asked to return all affected products for screening. Actions to be taken by the Customer/User: 1. If you have additional AEDs on hand , please quarantine and return any affected units as identified in the Attachment for screening or replacement. Do not include the pads and battery packs when you return your unit. 2. If no other AEDs are available, please continue using the device with caution until a loaner or replacement is provided. 3. Ensure that all users of the AED are informed of the product issue. Defibtech will provide support for handling all aspects of the return of identified units for screening. The firm will contact customers to help them with the process. If you have questions now, please contact the firm using the email address [email protected]. Additionally, Defibtech Customer Support is available by calling 1-877-453-4507, 8:30 A.M. to 5:30 P.M. (Eastern), Monday - Friday.
Quantity in commerce: 860
Distribution: Worldwide distribution - US Nationwide distribution and the countries of Australia, Canada, France, Malaysia, Mauritius, Netherlands, Thailand, United Arab Emirates.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2394-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2392-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-24	2020-06-17
Z-2393-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-24	2020-06-17
Z-2394-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-24	2020-06-17

Product code MKJ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)