# FDA recall Z-2102-2018

> **GE Healthcare** · Class II · device recall initiated 2018-01-25.

## Product

Centricity Universal Viewer    Product Usage:  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. Typical users of this system are trained professionals, including but not limited to radiologists, physicians, nurses, medical technicians, and assistants.

## Reason for recall

Potential that one or more  image series  may be missing from an exam without a user warning displayed in the Viewer.

## Distribution

Worldwide Distribution - US Nationwide in the states of AK, AZ, CA, CO, DE, FL, GA, HI, IA, ID, IL, LA, MA, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OK, OR. PA. SD, TN, TX, UT, WA, WI, WV, and WY and the countries of Austria, Belgium, Brazil, Canada, Colombia, France, Germany, Ghana, India, Ireland, Israel, Italy, Kuwait, Malaysia, Mexico, Netherlands, Panama, Poland, Russia, Saudi Arabia, South Africa, Spain, Switzerland, Turkey, United Arab Emirates, United Kingdomand Uruguay

## Key facts

- **Recall number:** Z-2102-2018
- **Recalling firm:** GE Healthcare
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-01-25
- **Report date:** 2018-06-13
- **Termination date:** 2023-11-02

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Chicago, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2102-2018

## Citation

> AI Analytics. FDA recall Z-2102-2018. Retrieved 2026-05-29 from https://api.ai-analytics.org/recall/Z-2102-2018. Source: US FDA. Licensed CC0.

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