# FDA recall Z-0140-2024

> **GE Healthcare** · Class II · device recall initiated 2023-09-14.

## Product

Centricity Universal Viewer, software versions 6.0 SP0 through 6.0 SP7.1; Radiological Image Processing System

## Reason for recall

GE HealthCare has become aware of an issue where images from two different patients may be contained in a single study, when stored in Centricity PACS-IW V3.7.x, Centricity PACS-IW with Universal Viewer V5.0 and Centricity Universal Viewer V6.0 with PACS-IW foundation.

## Distribution

US and Austria, Azerbaijan, Bosnia and Herzegovina, Brazil, Canada, Chile, Colombia, France, Germany, India, Ireland, Italy, Kuwait, Malaysia, Netherlands, Netherlands Antilles, Panama, Poland, Russia, Saudi Arabia, Slovenia, South Africa, Spain, Switzerland, United Kingdom, Uruguay, Venezuela, Vietnam

## Key facts

- **Recall number:** Z-0140-2024
- **Recalling firm:** GE Healthcare
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-09-14
- **Report date:** 2023-11-01

- **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-0140-2024

## Citation

> AI Analytics. FDA recall Z-0140-2024. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0140-2024. Source: US FDA. Licensed CC0.

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