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U.S. Department of Health and Human Services

Class 2 Device Recall Revolution CT with Apex Edition CT System

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  Class 2 Device Recall Revolution CT with Apex Edition CT System see related information
Date Initiated by Firm November 23, 2020
Create Date December 22, 2020
Recall Status1 Terminated 3 on August 29, 2023
Recall Number Z-0695-2021
Recall Event ID 86932
510(K)Number K191777  
Product Classification System, x-ray, tomography, computed - Product Code JAK
Product Revolution CT with Apex Edition CT System - Product Usage: intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.
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).    
Recalling Firm/
Manufacturer		 GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact
1800-437-1171
Manufacturer Reason
for Recall		 A potential for protocol(s) with unintended patient orientation or scan setting when using Intelligent Protocoling
FDA Determined
Cause 2		 Software in the Use Environment
Action A Recall notification letter titled, "URGENT MEDICAL DEVICE CORRECTION" was sent to consignees on 11/23/2020 via a parcel service. The letter instructs the consignee that they can continue to use their Revolution CT ES or Revolution CT with Apex Edition. They are asked to ensure that users review all protocols recommended by the system. It is important to confirm that the proper protocol is selected, and the patient orientation properly matches the protocol orientation picture in the Scan Settings window. If using the Intelligent Protocoling Autoselect preference, and more than one protocol is shown in the Selected Protocols window, the users are asked to carefully review these protocols to only select the appropriate one. The firm mentions that GE Healthcare will correct all affected products at no cost to the consignee. A GE Healthcare representative will contact the consignee to arrange for the correction. If the consignee has any questions, they are to contact GE Healthcare Service at 1-800-437-1171 or their local Service Representative.
Quantity in Commerce 3 units
Distribution Worldwide distribution - US Nationwide distribution including in the states of FL and TX. The countries of Belgium, France, and Spain.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JAK and Original Applicant = GE Medical Systems, LLC
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