# FDA recall Z-2004-2021

> **GE Healthcare, LLC** · Class II · device recall initiated 2021-03-19.

## Product

Revolution CT

## Reason for recall

GE Healthcare has become aware of a potential issue on the Revolution CT system where a collimator blade does not find its appropriate home position. This issue could result in the delivered dose of x-ray radiation being either larger or smaller than its prescribed value.

## Distribution

Worldwide distribution - US Nationwide

## Key facts

- **Recall number:** Z-2004-2021
- **Recalling firm:** GE Healthcare, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Completed
- **Initiation date:** 2021-03-19
- **Report date:** 2021-07-14

- **Voluntary/Mandated:** FDA Mandated
- **Location:** Waukesha, WI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2004-2021

## Citation

> AI Analytics. FDA recall Z-2004-2021. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/Z-2004-2021. Source: US FDA. Licensed CC0.

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