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U.S. Department of Health and Human Services

Class 2 Device Recall Revolution Apex, Revolution CT

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  Class 2 Device Recall Revolution Apex, Revolution CT see related information
Date Initiated by Firm June 30, 2021
Date Posted April 05, 2022
Recall Status1 Open3, Classified
Recall Number Z-0815-2022
Recall Event ID 89762
510(K)Number K163213  K191777  
Product Classification System, x-ray, tomography, computed - Product Code JAK
Product Revolution Apex, Revolution CT with Apex Edition
Code Information Revolution Apex, Revolution CT with Apex Edition
Recalling Firm/
GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact Healthcare Service
Manufacturer Reason
for Recall
The accumulated dose is incorrectly displayed in certain situations. There are two situations that will result in the SmartStep displayed dose being inaccurately high.
FDA Determined
Cause 2
Radiation Control for Health and Safety Act
Action GE Healthcare sent an Important Electronic Product Radiation Warning letter dated February 8, 2022 to all affected systems informing its users of the potential for the issue to occur and instruct the users as to what actions to take. GE Healthcare will, without charge, remedy the defect or bring the product into compliance with each applicable Federal standard in accordance with a plan to be approved by the Secretary of Health and Human Services, the details of which will be included in a subsequent communication to you or through a GE Healthcare field engineer site visit. For questions contact GE Healthcare Services at 1 (800) 437-1171 or local Service Representative.
Quantity in Commerce 273 (51 US, 222 OUS) in total
Distribution Worldwide - US Nationwide distribution.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = JAK and Original Applicant = GE Medical Systems, L.L.C.
510(K)s with Product Code = JAK and Original Applicant = GE Medical Systems, LLC