# FDA recall Z-0721-2023

> **GE Medical Systems, LLC** · Class II · device recall initiated 2022-10-28.

## Product

Centricity PACS-IW with Universal Viewer version 5.0.      Used to display medical images (Including mammograms) and data from various imaging sources.

## Reason for recall

There is the potential that after installation of the IAS tool, some studies can remain hidden without user notification. Access to those hidden studies requires GE Healthcare assistance, which can result in a delay in reading the study.

## Distribution

Nationwide distribution to CA, CO, DE, FL, IA, IL, MA, MI, MN, MO, MS, MT, ND, NJ, NY, OK, OR, SD, TX, WI, WV, WY.    International distribution to Austria, Brazil, France, Germany, Ghana, Ireland, Italy, Kuwait, Poland, Saudi Arabia, South Africa, Spain, Switzerland, United Kingdom.

## Key facts

- **Recall number:** Z-0721-2023
- **Recalling firm:** GE Medical Systems, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-10-28
- **Report date:** 2022-12-28

- **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-0721-2023

## Citation

> AI Analytics. FDA recall Z-0721-2023. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-0721-2023. Source: US FDA. Licensed CC0.

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