Z-0694-2021 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- December 30, 2020
- Initiation Date
- November 23, 2020
- Termination Date
- August 29, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2 units
Product Description
Revolution CT ES - Product Usage: intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.
Reason for Recall
A potential for protocol(s) with unintended patient orientation or scan setting when using Intelligent Protocoling
Distribution Pattern
Worldwide distribution - US Nationwide distribution including in the states of FL and TX. The countries of Belgium, France, and Spain.
Code Information
Model Number: 5995001-6; Serial Number's: REVV81900024CN (System ID:561955REV/UDI: 01008406821234711119070021REVV81900024CN) and REVV81900022CN (System ID: DPN80000/ UDI:01008406821234711119070021REVV81900022CN).