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U.S. Department of Health and Human Services

Class 2 Device Recall Revolution CT

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  Class 2 Device Recall Revolution CT see related information
Date Initiated by Firm March 19, 2021
Date Posted July 08, 2021
Recall Status1 Open3, Classified
Recall Number Z-2004-2021
Recall Event ID 88150
510(K)Number K133705  K163213  K191777  
Product Classification System, x-ray, tomography, computed - Product Code JAK
Product Revolution CT
Code Information 5590000 5590000-6 5590000-2
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		 GE Healthcare has become aware of a potential issue on the Revolution CT system where a collimator blade does not find its appropriate home position. This issue could result in the delivered dose of x-ray radiation being either larger or smaller than its prescribed value.
FDA Determined
Cause 2		 Radiation Control for Health and Safety Act
Action GE Healthcare will perform an initial site assessment and replace the collimator, if needed. This will be followed by bi-weekly remote monitoring of the system s log file. Finally, GE Healthcare will install a currently under development software patch, added to the daily fast calibration to automatically and reliably detect this failure should it occur. All of these actions will be performed at no cost to the customer. For questions call 262-544-3217.
Quantity in Commerce 197 (US = 40; OUS = 157)
Distribution Worldwide distribution - US Nationwide
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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