Recall Z-0695-2021— GE Healthcare, LLC

Name: FDA recall Z-0695-2021
Creator: U.S. Food and Drug Administration
Published: 2020-11-23

Class II · Terminated

Class II FDA medical device recall by GE Healthcare, LLC, initiated 2020-11-23, terminated 2023-08-29. It names one FDA 510(k) clearance: K191777. Product: Revolution CT with Apex Edition CT System - Product Usage: intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.. Reason: A potential for protocol(s) with unintended patient orientation or scan setting when using Intelligent Protocoling.

Recalling firm: GE Healthcare, LLC
Classification: Class II
Status: Terminated
Initiated: 2020-11-23
Terminated: 2023-08-29
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K191777 — Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex editionGe Medical Systems, LLC·cleared 2019-07-26

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.