Device product
Revolution CT with Apex Edition CT System - Product Usage: intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.
Z-0695-2021
Product summary
- Event
- Event 86932
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3 units
- Official record key
device-enforcement:Z-0695-2021
Official wording
Reason: A potential for protocol(s) with unintended patient orientation or scan setting when using Intelligent Protocoling
Code information: Model Number: 5995000-5; Serial Number's: REVVX1700078CN (System ID: 713MMREVCT/UDI: 01008406821185521117070021REVVX1700078CN) , 00000440315CN0 (System ID: 220078CT04), and REVVX1800040CN (System ID: M2322265/UDI: 01008406821185521118030021REVVX1800040CN).
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