# FDA recall Z-1886-2019

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

## Product

Centricity Universal Viewer with PACS-IW foundation 6.0, Model number 2090255-001      Product Usage: Centricity PACS-IW with Universal Viewer is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, communicated, processed and displayed within the system or across computer networks at distributed locations. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Megapixel resolution and meet other technical specifications reviewed and accepted by the FDA.

## 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-1886-2019
- **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-1886-2019

## Citation

> AI Analytics. FDA recall Z-1886-2019. Retrieved 2026-07-03 from https://api.ai-analytics.org/recall/Z-1886-2019. Source: US FDA. Licensed CC0.

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