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U.S. Department of Health and Human Services

Class 2 Device Recall Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition

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  Class 2 Device Recall Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition see related information
Date Initiated by Firm June 30, 2021
Date Posted November 24, 2021
Recall Status1 Open3, Classified
Recall Number Z-0242-2022
Recall Event ID 89027
510(K)Number K163213  K191777  K133705  
Product Classification System, x-ray, tomography, computed - Product Code JAK
Product Computed Tomography Systems
Revolution CT,
Revolution CT ES,
Revolution Apex,
Revolution CT with Apex edition
Code Information Revolution CT,  Revolution CT ES,  Revolution Apex,  Revolution CT with Apex edition
Recalling Firm/
Manufacturer		 GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact Healthcare Service
800-437-1171
Manufacturer Reason
for Recall		 The accumulated dose is incorrectly displayed in certain situations. Thisoccurs during an interventional exam using the SmartStep option if the table height is adjusted after the exam starts. In this situation, the SmartStep display will show a value that is higher (up to 100 times) than the actual dose delivered.
FDA Determined
Cause 2		 Radiation Control for Health and Safety Act
Action GE sent an Important Electronic Product Radiation Warning Notification letter dated October 4, 2021 to customers, The letter identified the affected product, problem and actions to be taken. Customers were informed that 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 Service at 1-800-437-1171 or your local Service Representative.
Quantity in Commerce 105 in total
Distribution Worldwide and 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
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