# FDA recall Z-0819-2020

> **GE Healthcare, LLC** · Class II · device recall initiated 2019-12-16.

## Product

Centricity Universal Viewer 6.0, a device that displays medical images and data from various imaging sources, and from other healthcare information sources.

## Reason for recall

Centricity Universal Viewer measurements saved into a DICOM Grayscale Presentation State are incorrect in subsequent views for exams containing series with different pixel sizes and may lead to a potential misdiagnosis.

## Distribution

Distributed nationwide; Internationally distributed to Mexico and 24 additional countries.

## Key facts

- **Recall number:** Z-0819-2020
- **Recalling firm:** GE Healthcare, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-12-16
- **Report date:** 2020-01-29
- **Termination date:** 2023-10-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Waukesha, WI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0819-2020

## Citation

> AI Analytics. FDA recall Z-0819-2020. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0819-2020. Source: US FDA. Licensed CC0.

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