# FDA recall Z-0608-2020

> **Philips North  America, LLC** · Class II · device recall initiated 2019-10-03.

## Product

HeartStart XL+ Defibrillator/Monitor, Model 861290

## Reason for recall

Device may fail to turn on or unexpectedly attempt to restart, rendering it unable to return to a ready for use state. Additionally, this issue may occur when the device is in standby mode, when attempting to power on to run a self-test. If this occurs, the device will indicate that it is not ready for use.

## Distribution

US Nationwide

## Key facts

- **Recall number:** Z-0608-2020
- **Recalling firm:** Philips North  America, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-10-03
- **Report date:** 2019-12-11
- **Termination date:** 2023-04-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Andover, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0608-2020

## Citation

> AI Analytics. FDA recall Z-0608-2020. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-0608-2020. Source: US FDA. Licensed CC0.

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