DDU-2450 Lifeline ECG Model Numbers DDU-A2450EN DDU-E2450DE… — Class II medical device recall Z-2394-2020
Terminated recall by Defibtech, LLC, reported 2020-06-24, distributed nationwide. A component issue may cause the AED to abort a shock delivery or reset unexpectedly, which may cause an affect
| Recall number | Z-2394-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Defibtech, LLC, Guilford, CT, United States |
| Recall initiated | 2020-04-27 |
| Classified | 2020-06-17 |
| Reported by FDA | 2020-06-24 |
| Terminated | 2021-01-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, CA, FR, MY, NL, TH |
| Quantity | 860 |
| UPC / GTIN / UDI-DI | 00815098020287, 00815098020317 |
| 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 and 69 more |
| Model numbers | DCF-A2460EN, DCF-A2463EN, DCF-E2460DE, DCF-E2460EN, DCF-E2460FR, DCF-E2460TH, DDU-A2450EN, DDU-E2450DE, DDU-E2450EN, DDU-E2450FR, DDU-E2450TH |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2394-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.