FDA Medical Device Recalls (openFDA)
Defibtech, LLC: 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.
- Recall number
- Z-2393-2020
- Recalling firm
- Defibtech, LLC
- 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.
- Status
- Terminated
- Initiated
- 2020-04-27
- Posted
- not on file
- Terminated
- 2021-01-08
- Reason
- 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
- 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 FA2020@defibtech.com. 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
- 860
- Distribution
- Worldwide distribution - US Nationwide distribution and the countries of Australia, Canada, France, Malaysia, Mauritius, Netherlands, Thailand, United Arab Emirates.
- Lot, serial or model codes
- Serial Number 400101322
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MKJ
- Firm FEI
- 3003521780
- Firm city
- Guilford
- Firm state
- CT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28