Z-0776-2019 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- February 13, 2019
- Initiation Date
- July 12, 2018
- Termination Date
- N/A
- 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