# FDA recall Z-0012-2022

> **GE Healthcare, LLC** · Class II · device recall initiated 2021-08-12.

## Product

Centricity Universal Viewer 7.0, Model 5829628-0XX.  Radiological image processing system

## Reason for recall

A software anomaly exists in the Centricity Universal Viewer study management feature in which study changes are not propagated to either the Centricity Enterprise Archive (EA) or another Vendor Neutral Archive (VNA).

## Distribution

AR, IL, ME, MS, NE, NJ, NY,  and TN  Belgium, Canada, Costa Rica, France, Germany, India, Japan, Korea, Kuwait, Saudi Arabia, Singapore, Switzerland, Switzerland, Turkey and United Kingdom

## Key facts

- **Recall number:** Z-0012-2022
- **Recalling firm:** GE Healthcare, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-08-12
- **Report date:** 2021-10-13
- **Termination date:** 2024-08-22

- **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-0012-2022

## Citation

> AI Analytics. FDA recall Z-0012-2022. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-0012-2022. Source: US FDA. Licensed CC0.

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