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U.S. Department of Health and Human Services

Class 2 Device Recall GE Revolution CT computed tomography xray systems

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  Class 2 Device Recall GE Revolution CT computed tomography xray systems see related information
Date Initiated by Firm November 12, 2014
Date Posted January 26, 2015
Recall Status1 Terminated 3 on April 29, 2015
Recall Number Z-0955-2015
Recall Event ID 70133
510(K)Number K133705  
Product Classification System, x-ray, tomography, computed - Product Code JAK
Product The Revolution CT is a multi-slice (256 detector row) CT scanner consisting of a gantry, patient table, scanner desktop (operator console), system cabinet, power distribution unit (POU). and interconnecting cables.The system includes image acquisition hardware, image acquisition and reconstruction software, and associated accessories.
Code Information Software version: 14MW14.29
Recalling Firm/
Manufacturer		 GE Healthcare
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact
262-513-4122
Manufacturer Reason
for Recall		 A required quality control test was not performed during installation associated with the software of the Revolution CT scanner.
FDA Determined
Cause 2		 Radiation Control for Health and Safety Act
Action GE Healthcare Planned Action (s) to repair defect or to bring product into Compliance letter dated January 16, 2015 to GE Healthcare. 1. A GE Healthcare service representative will perform a noise specification and tolerance calibration to correct all affected systems via Field Action Instruction (FMI 25457). 2. A customer notification letter which includes a statement that GE Healthcare will without charge, remedy the defect or bring the product into compliance. CDRH approves the CAP subject to the following conditions: 1. Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification. 2. GE Healthcare Surgery will implement this CAP by May 1, 2015. You may proceed or continue with implementation of the CAP (subject to the conditions noted above). Call Center phone numbers: United States: 800 437-1171, Japan: 0120-055-919 Information For other countries, please contact your local GE Healthcare Service Representative if you have any questions or concerns regarding this notification.
Quantity in Commerce 13 units
Distribution US Distribution to the states of CA, FL, IL, NY, UT and WA.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JAK and Original Applicant = GE MEDICAL SYSTEMS, LLC
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