Device product
Revolution CT ES - Product Usage: intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.
Z-0694-2021
Product summary
- Event
- Event 86932
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2 units
- Official record key
device-enforcement:Z-0694-2021
Official wording
Reason: A potential for protocol(s) with unintended patient orientation or scan setting when using Intelligent Protocoling
Code information: Model Number: 5995001-6; Serial Number's: REVV81900024CN (System ID:561955REV/UDI: 01008406821234711119070021REVV81900024CN) and REVV81900022CN (System ID: DPN80000/ UDI:01008406821234711119070021REVV81900022CN).
Distribution pattern: Worldwide distribution - US Nationwide distribution including in the states of FL and TX. The countries of Belgium, France, and Spain.
Derived failure modes
-
Unknown
A potential for protocol(s) with unintended patient orientation or scan setting when using Intelligent Protocoling