# FDA recall Z-0776-2019

> **GE Healthcare, LLC** · Class II · device recall initiated 2018-07-12.

## Product

Revolution CT systems with the SmartStep Option    The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.

## Reason for recall

On the Revolution CT systems equipped with the SmartStep Option, the Z location displayed on image annotation and on the gantry display may not be the actual location of the table and result in the system scanning at a location that is not what was confirmed by the operator

## Distribution

Worldwide Distribution - US (Nationwide Distribution) and countries of: Australia, Belgium, Canada, Estonia, Finland, France, Germany, Hong Kong, Ireland, Japan, Korea Republic of, Malaysia, Morocco, New Zealand, Norway, Saudi Arabia, Singapore, Slovakia, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, and United Kingdom.

## Key facts

- **Recall number:** Z-0776-2019
- **Recalling firm:** GE Healthcare, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2018-07-12
- **Report date:** 2019-02-13

- **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-0776-2019

## Citation

> AI Analytics. FDA recall Z-0776-2019. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/Z-0776-2019. Source: US FDA. Licensed CC0.

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