# FDA recall Z-0978-2018

> **Philips Electronics North  America Corporation** · Class III · device recall initiated 2018-02-07.

## Product

HeartStart XL+ Defibrillator/Monitor    The HeartStart XL+ is intended for use in a hospital setting by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced life support, or defibrillation. It must be used by or on the order of a physician. When operating as a semi-automatic external defibrillator in AED Mode, the HeartStart XL+ is suitable for use by medical personnel trained in basic life support that includes use of an AED. When operating in Monitor, Manual Defib, or Pacer Mode, the HeartStart XL+ is suitable for use by healthcare professionals trained in advanced life support.

## Reason for recall

Update XL¿ device software to  version A.03.  This includes enhancements to the Operational Checks, event logs, and troubleshooting messages that provide as complete of information as needed to users on  device readiness.

## Distribution

Foreign Only - China

## Key facts

- **Recall number:** Z-0978-2018
- **Recalling firm:** Philips Electronics North  America Corporation
- **Classification:** Class III
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-02-07
- **Report date:** 2018-03-21
- **Termination date:** 2020-02-07

- **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-0978-2018

## Citation

> AI Analytics. FDA recall Z-0978-2018. Retrieved 2026-07-02 from https://api.ai-analytics.org/recall/Z-0978-2018. Source: US FDA. Licensed CC0.

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