# FDA recall Z-1911-2019

> **GE Healthcare, LLC** · Class II · device recall initiated 2019-05-16.

## Product

Centricity PACS Foundation    Centricity PACS software product is intended for the storage, reading, diagnostic review, analysis, annotation, distribution, printing, editing, and processing of digital images and data acquired from diagnostic imaging devices.

## Reason for recall

There is the possibility of viewing studies directly from the Enterprise Archive or VNA with incorrect patient images because the updated series or study is not present in the archive.

## Distribution

Worldwide Distribution: US (nationwide) to states of: FL, GA, IL, IN, LA, MA, MO, NJ, NY, OR, PA, SC, SD, TX, and WA; and countries of : Brazil, Canada, Chile, France, French Polynesia, Germany, India, Italy, Japan, Kuwait, Lebanon, Singapore, Spain and United Kingdom.

## Key facts

- **Recall number:** Z-1911-2019
- **Recalling firm:** GE Healthcare, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-05-16
- **Report date:** 2019-07-10
- **Termination date:** 2023-04-14

- **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-1911-2019

## Citation

> AI Analytics. FDA recall Z-1911-2019. Retrieved 2026-06-16 from https://api.ai-analytics.org/recall/Z-1911-2019. Source: US FDA. Licensed CC0.

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