# FDA recall Z-0816-2022

> **GE Healthcare, LLC** · Class II · device recall initiated 2021-06-30.

## Product

Revolution CT, Revolution CT ES

## Reason for recall

The accumulated dose is incorrectly displayed in certain situations. There are two situations that will result in the SmartStep displayed dose being inaccurately high.

## Distribution

Worldwide - US Nationwide distribution.

## Key facts

- **Recall number:** Z-0816-2022
- **Recalling firm:** GE Healthcare, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-06-30
- **Report date:** 2022-04-13

- **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-0816-2022

## Citation

> AI Analytics. FDA recall Z-0816-2022. Retrieved 2026-06-05 from https://api.ai-analytics.org/recall/Z-0816-2022. Source: US FDA. Licensed CC0.

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