Z-0776-2019 Class II Ongoing
FDA device recall Z-0776-2019 was initiated by GE Healthcare, LLC on Jul 12, 2018 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 131 units.
Recall Details
- Product Type
- Devices
- Report Date
- Feb 13, 2019
- Initiation Date
- Jul 12, 2018
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- 131 units
Product Description
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 Pattern
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.
Code Information
SmartStep Option
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0776-2019
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026