medical Class II Updated 2020-12-30

GE Healthcare, LLC recalls Revolution CT with Apex Edition CT System - Product Usage: i

Recalled Product

Revolution CT with Apex Edition CT System - Product Usage: intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.


Hazard / Issue

A potential for protocol(s) with unintended patient orientation or scan setting when using Intelligent Protocoling

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Model Number: 5995000-5; Serial Number's: REVVX1700078CN (System ID: 713MMREVCT/UDI: 01008406821185521117070021REVVX1700078CN) , 00000440315CN0 (System ID: 220078CT04), and REVVX1800040CN (System ID: M2322265/UDI: 01008406821185521118030021REVVX1800040CN).
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