# FDA recall Z-2393-2020

> **Defibtech, LLC** · Class II · device recall initiated 2020-04-27.

## 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.

## 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.

## Distribution

Worldwide distribution - US Nationwide distribution and the countries of Australia, Canada, France, Malaysia, Mauritius, Netherlands, Thailand, United Arab Emirates.

## Key facts

- **Recall number:** Z-2393-2020
- **Recalling firm:** Defibtech, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-04-27
- **Report date:** 2020-06-24
- **Termination date:** 2021-01-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Guilford, CT, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2393-2020

## Citation

> AI Analytics. FDA recall Z-2393-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2393-2020. Source: US FDA. Licensed CC0.

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