GE Healthcare, LLC: Medical Device Recall in 2020 - (Recall #: Z-0694-2021)

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 ES - 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-0694-2021

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: 2 units

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.

Voluntary or Mandated:

Voluntary: Firm initiated