# FDA recall Z-1885-2019

> **GE Healthcare, LLC** · Class II · device recall initiated 2019-05-17.

## Product

Centricity PACS-IW with Universal Viewer version 5.0, Model Number 2068177-001    Product Usage:  Centricity Universal Viewer is a device that displays medical images and data from various imaging sources, and from other healthcare information sources. Medical images and data can be displayed, communicated, stored, and processed. Typical users of this system are authorized healthcare professionals. Centricity Universal Viewer is intended to assist in the viewing, analysis, diagnostic interpretation, and sharing of images and other information. Mammography images may only be interpreted using a monitor compliant with requirements of local regulations and must meet other technical specifications reviewed and accepted by the local regulatory agencies. Contraindications: Centricity Universal Viewer is contraindicated for the use of lossy compressed mammographic images. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretatio

## Reason for recall

There is a potential that one or more images or image series may be missing from exams without a warning displayed in the viewer.

## Distribution

Worldwide Distribution - US Nationwide Austria, Belgium,  Brazil  Canada  Colombia  France  Germany  Ghana  India  Ireland  Israel  Italy  Kuwait  Mexico  Netherlands  Panama  Poland  Qatar  Russia  Saudi Arabia  Slovenia  South Africa  Spain  Switzerland  Turkey  United Arab Emirates  United Kingdom  Uruguay

## Key facts

- **Recall number:** Z-1885-2019
- **Recalling firm:** GE Healthcare, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-05-17
- **Report date:** 2019-07-03
- **Termination date:** 2023-11-20

- **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-1885-2019

## Citation

> AI Analytics. FDA recall Z-1885-2019. Retrieved 2026-07-19 from https://api.ai-analytics.org/recall/Z-1885-2019. Source: US FDA. Licensed CC0.

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