# FDA recall Z-1773-2021

> **CHANGE HEALTHCARE CANADA COMPANY** · Class II · device recall initiated 2021-04-19.

## Product

Change Healthcare Enterprise Viewer - Product Usage: intended to be used with off-the-shelf hardware for the 2D and 3D display of DICOM and non-DICOM medical images, reports, and multimedia content.

## Reason for recall

A software defect was identified where the Image Styles defined by presentation states from CHRS are not displayed in CHEV.

## Distribution

US Nationwide distribution in the states of AK, AR, AZ, CA, FL, HI, IA, IN, IL, KY, NE, NY, MA,  MI, MS, OH, PA, TX,TN, WA, WI, WY.

## Key facts

- **Recall number:** Z-1773-2021
- **Recalling firm:** CHANGE HEALTHCARE CANADA COMPANY
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-04-19
- **Report date:** 2021-06-09

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1773-2021

## Citation

> AI Analytics. FDA recall Z-1773-2021. Retrieved 2026-06-30 from https://api.ai-analytics.org/recall/Z-1773-2021. Source: US FDA. Licensed CC0.

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