# FDA recall Z-2064-2020

> **Philips North  America, LLC** · Class II · device recall initiated 2020-04-10.

## Product

HeartStart MRx Processor Board PCA Replacement Kits  453563478461, a component of the Philips HeartStart MRx Monitorl/Defibrillator - Product Usage: is intended for use in hospital and prehospital settings by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac life support or defibrillation.

## Reason for recall

Damaged ESD bags used for storing components in  Processor PCA Replacement Kits

## Distribution

Worldwide distribution - US Nationwide distribution including in the states of OK, NY and the countries of Libya, Netherlands, Canada, South Africa, United Kingdom.

## Key facts

- **Recall number:** Z-2064-2020
- **Recalling firm:** Philips North  America, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-04-10
- **Report date:** 2020-05-27
- **Termination date:** 2021-02-10

- **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-2064-2020

## Citation

> AI Analytics. FDA recall Z-2064-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2064-2020. Source: US FDA. Licensed CC0.

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