Z-0816-2022 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- April 13, 2022
- Initiation Date
- June 30, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- 273 (51 US; 222 OUS) in total
Product Description
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 Pattern
Worldwide - US Nationwide distribution.
Code Information
Revolution CT, Revolution CT ES