Class 2 Device Recall Revolution Apex, Revolution CT with Apex Edition

• Date Initiated by Firm: September 21, 2020
• Create Date: October 29, 2020
• Recall Status: Terminated on December 28, 2022
• Recall Number: Z-0306-2021
• Recall Event ID: 86544
• 510(K)Number: K191777
• Product Classification: System, x-ray, tomography, computed - Product Code JAK
• Product: Revolution Apex, Revolution CT with Apex Edition, Model 5995000-5 - Product Usage: The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.
• Code Information: Model 5995000-5; Lot/Serial Numbers as below: REVVX1800093CN REVVX1700044CN REVVX1900040CN REVVX2000001CN REV2A1900002CN REV2A2000014CN REVVX2000031CN REV2A2000013CN REVVX1600023CN REVVX1800015CN REVVX1900092CN REV2A2000006CN REVVX1900003CN REV2A2000003CN REV2A2000015CN REV2A1900003CN REVVX1800061CN REV2A2000007CN REVVX1700078CN REVVX1900071CN REVVX1900006CN REVVX1900003CN REVVX1800124CN REVVX1800030CN 441066CN8 00000436942CN7 REV2A2000010CN 00000442968CN4 REVVX1900049CN 00000439505CN9 REVVX1700064CN 00000440315CN0 REV2A2000017CN DUMFMI25490001 REV2A2000001CN 00000442412CN3 REV2A2000002CN REVVX1700054CN REVVX1800100CN REV2A2000012CN REVVX1800040CN REVVX1600046CN REV2A2000016CN REGGL2000003YC REVVX1900013CN REVVX1600030CN REV2A1900001CN REVVX1700117CN REVVX1800083CN REVVX1700106CN 00000440441CN4 REV2A2000018CN REV2A1900005CN REV2A2000009CN 00000438438CN4 REVVX1900102CN REV2A2000011CN REV2A2000004CN DUMFMI25490005 4 included units with lot/serials not available.
• Recalling Firm/ Manufacturer: GE Healthcare, LLC; 3000 N Grandview Blvd; Waukesha WI 53188-1615
• For Additional Information Contact: GE Healthcare Service; 800-437-1171
• Manufacturer Reason for Recall: There is a potential for a smudge artifact that could be suspect for pathology in some images due to incorrect settings.
• FDA Determined Cause: Device Design
• Action: The recall strategy outlined below addresses the depth of the recall and recall notification (customer letter) effectiveness check. This issue will be resolved by sending an Urgent Medical Device Correction letter (attached) to customers with potentially affected systems. This letter will inform the customer of the issue and provide safety instructions for continued use. GE Healthcare will inspect potentially affected systems and correct, if needed. In the U.S., this letter will be sent by a traceable means. This letter will be sent to the following titles within the affected accounts: Director of Clinical/Radiology, Risk Manager/Hospital Administrator, Director of Biomedical Engineering. GE Healthcare will document customer acknowledgment of the receipt and understanding of the letter, and the inspection and correction, if needed, of potentially affected systems. Records will be retained per our processes and procedures.
• Quantity in Commerce: 64 devices
• Distribution: Worldwide distribution - US Nationwide distribution including in the states of FL, GA, IL, MI, NC, NE, NJ, PA, TX, VA, WA, and WI. The countries of Australia, Austria, Belgium, Canada, China, Denmark, Estonia, Finland, France, Japan, Kuwait, Norway, Saudi Arabia, Spain, Sweden, Switzerland, Thailand, and United Kingdom.
• 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