# FDA recall Z-2502-2021

> **GE Healthcare, LLC** · Class II · device recall initiated 2021-08-06.

## Product

Centricity PACS-IW with Universal Viewer - Product Usage: Is a device that displays medical images (including mammograms) and data from various imaging sources.

## Reason for recall

Image acquisition failures and synchronization failure with the Centricity Enterprise Archive

## Distribution

AK, AZ, CA, CO, DE, FL, GA, IA, IN, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TX, UT, WA, WI, WV and  WY. Austria, Brazil, Canada, France, Germany, Ghana, India, Ireland, Israel, Italy, Kuwait, Netherlands, Panama, Poland, Russia, Saudi Arabia, Slovenia, South Africa, Spain, Switzerland, Turkey, United Kingdom and Uruguay.

## Key facts

- **Recall number:** Z-2502-2021
- **Recalling firm:** GE Healthcare, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-08-06
- **Report date:** 2021-09-29

- **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-2502-2021

## Citation

> AI Analytics. FDA recall Z-2502-2021. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-2502-2021. Source: US FDA. Licensed CC0.

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