FDA recall Z-0695-2021

Product

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

Worldwide distribution - US Nationwide distribution including in the states of FL and TX. The countries of Belgium, France, and Spain.

Key facts

Status

Terminated

Initiation date

2020-11-23

Report date

2020-12-30

Termination date

2023-08-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Waukesha, WI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0695-2021