# FDA recall Z-0854-2019

> **Philips North  America, LLC** · Class II · device recall initiated 2019-01-09.

## Product

PageWriter TC50, Product 860310, Software revisions up to and including A.07.05.22 used to evaluate the electrocardiogram of adult and pediatric patients

## Reason for recall

Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to melt and/or the device to ignite, which can cause injury to patient or nearby users.

## Distribution

Domestic distribution nationwide. Foreign distribution worldwide.

## Key facts

- **Recall number:** Z-0854-2019
- **Recalling firm:** Philips North  America, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2019-01-09
- **Report date:** 2019-02-27

- **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-0854-2019

## Citation

> AI Analytics. FDA recall Z-0854-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0854-2019. Source: US FDA. Licensed CC0.

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