GE Healthcare, LLC: Medical Device Recall in 2020 - (Recall #: Z-0695-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: November 23, 2020

Date Posted: December 30, 2020

Recall Number: Z-0695-2021

Event ID: 86932

Reason for Recall:

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

Status: Terminated

Product Quantity: 3 units

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.

Voluntary or Mandated:

Voluntary: Firm initiated