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U.S. Department of Health and Human Services

Class 2 Device Recall Xray Computed Tomography

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  Class 2 Device Recall Xray Computed Tomography see related information
Date Initiated by Firm January 19, 2019
Create Date July 12, 2019
Recall Status1 Open3, Classified
Recall Number Z-1951-2019
Recall Event ID 83254
510(K)Number K133705  K163213  
Product Classification System, x-ray, tomography, computed - Product Code JAK
Product Revolution CT scanners

Product Usage: The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.
Code Information Revolution CT
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		 Additional low dose radiation exposure.
FDA Determined
Cause 2		 Device Design
Action GE Healthcare will send a customer letter that provide safety instructions for immediate mitigation of the issue. The customer can continue to use the system with the recommended workaround instruction provided in the customer letter: All affected systems will be corrected with updated software and a User Manual Addendum which re-emphasizes existing pat ient center ing instructions. If you have any questions or concerns regarding this notification. For question contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
Quantity in Commerce 857 (US = 195: OUS = 662)
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
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