# FDA recall Z-0294-2018

> **Physio-Control, Inc.** · Class I · device recall initiated 2017-12-04.

## Product

LIFEPAK 20e DEFIBRILLATOR/MONITOR, 3201273    Product Usage:  The LIFEPAK 20e defibrillator/monitor is intended for use in the hospital, physician s office, and clinic setting by personnel who are authorized by a physician/medical director. It is intended for use on a  crash cart  as well as for portable emergency response throughout a hospital.

## Reason for recall

Physio-Control is aware that some devices have had power-related failures as customers prepared their device for initial deployment or during use within the first year of distribution. The symptoms of these failures may include unexpected power on and power off, device lock-up, or a failure to power on or off, any of which has the potential to result in a failure to deliver therapy to the patient and serious injury or death.

## Distribution

Worldwide Distribution

## Key facts

- **Recall number:** Z-0294-2018
- **Recalling firm:** Physio-Control, Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-12-04
- **Report date:** 2018-01-17
- **Termination date:** 2024-04-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Redmond, WA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0294-2018

## Citation

> AI Analytics. FDA recall Z-0294-2018. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0294-2018. Source: US FDA. Licensed CC0.

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