# FDA recall Z-1533-2021

> **GE Healthcare, LLC** · Class II · device recall initiated 2021-03-19.

## Product

Centricity Universal Viewer - Product Usage:  intended to assist in the viewing, analysis, diagnostic interpretation, and sharing of images and other information.

## Reason for recall

When the Cross Enterprise Display option is enabled on the Centricity Universal Viewer and Workflow  Manager option is used as the PACS worklist launching the viewer, the patient jacket may potentially include a different patient s comparison exam(s).

## Distribution

Distributed nationwide to AR, CA, CO, DE, FL, IL, IN, LA, ME, NE, NJ, NV, NY, PA, SC, TX and internationally to Canada.

## Key facts

- **Recall number:** Z-1533-2021
- **Recalling firm:** GE Healthcare, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-03-19
- **Report date:** 2021-05-12
- **Termination date:** 2023-08-11

- **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-1533-2021

## Citation

> AI Analytics. FDA recall Z-1533-2021. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1533-2021. Source: US FDA. Licensed CC0.

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