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U.S. Department of Health and Human Services

Class 2 Device Recall Revolution EVO Optima CT660 and Optima CT680

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  Class 2 Device Recall Revolution EVO Optima CT660 and Optima CT680 see related information
Date Initiated by Firm June 14, 2021
Create Date June 25, 2021
Recall Status1 Open3, Classified
Recall Number Z-1900-2021
Recall Event ID 88116
510(K)Number K131576  
Product Classification System, x-ray, tomography, computed - Product Code JAK
Product Revolution EVO, Optima CT660, Optima CT680 CT Systems.
Code Information Optima CT660 12HW28.8 14HW30.3 15HW25.2 13HW38.14 15HW13.7 Revolution EVO 14HW17.4 15HW13.7 Optima CT680 13HW38.14 15BW21.2 
Recalling Firm/
Manufacturer		 GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact
800-437-1171
Manufacturer Reason
for Recall		 Improperly loaded software options may result in additional X -ray radiation exposure to the patient.
FDA Determined
Cause 2		 Radiation Control for Health and Safety Act
Action GE Healthcare will send an Important Electronic Product Radiation Warning letter 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 to prevent this issue.
Quantity in Commerce 3665
Distribution 3,665 (US = 956; OUS = 2,709)
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, LLC
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