Z-0695-2021 Class II Terminated
FDA device recall Z-0695-2021 was initiated by GE Healthcare, LLC on November 23, 2020 and is designated Class II. Reason for recall: A potential for protocol(s) with unintended patient orientation or scan setting when using Intelligent Protocoling The recall status is terminated (terminated August 29, 2023). Affected quantity: 3 units.
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
- 3 units
Product Description
Revolution CT with Apex Edition CT System - 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: 5995000-5; Serial Number's: REVVX1700078CN (System ID: 713MMREVCT/UDI: 01008406821185521117070021REVVX1700078CN) , 00000440315CN0 (System ID: 220078CT04), and REVVX1800040CN (System ID: M2322265/UDI: 01008406821185521118030021REVVX1800040CN).