# FDA recall Z-1682-2020

> **CHANGE HEALTHCARE CANADA COMPANY** · Class II · device recall initiated 2020-02-10.

## Product

McKesson Cardiology ECG Management, Change Healthcare Cardiology ECG Management

## Reason for recall

Inaccurate estimation of the heart rate may occur in instances where the user is estimating heart rate counting grid squares using the Sequential ECG format

## Distribution

Distribution US nationwide, Canada and the United Kingdom

## Key facts

- **Recall number:** Z-1682-2020
- **Recalling firm:** CHANGE HEALTHCARE CANADA COMPANY
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2020-02-10
- **Report date:** 2020-04-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Richmond, British Columbia, Canada

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1682-2020

## Citation

> AI Analytics. FDA recall Z-1682-2020. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/Z-1682-2020. Source: US FDA. Licensed CC0.

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