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U.S. Department of Health and Human Services

Class 2 Device Recall CT Goldseal Optima CT 600

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  Class 2 Device Recall CT Goldseal Optima CT 600 see related information
Date Initiated by Firm May 24, 2018
Create Date July 31, 2018
Recall Status1 Terminated 3 on February 08, 2019
Recall Number Z-2583-2018
Recall Event ID 80484
510(K)Number K110227  K131576  
Product Classification System, x-ray, tomography, computed - Product Code JAK
Product CT Goldseal Optima CT 600
Code Information Serial Number 51941YC3, System ID Number 406434660 
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		 Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be properly wired to the partial system UPS (Uninteruptible Power Supply).
FDA Determined
Cause 2		 Component change control
Action GE Healthcare notified customers on about 05/24/2018 via URGENT MEDICAL DEVICE CORRECTION letter. The letter outlined the reason for recall and notified customers that a GE Healthcare representative would be contacting them to arrange for the correction of the devices. Any questions or concerns can be directed to GE Healthcare Service at 1-800-437-1171 or a local Service Representative.
Quantity in Commerce 42 units total
Distribution Nationwide distribution to AL, CA, CO, FL, IL, IN, MA, MD, MI, MS, NC, NJ, NY,OH, OK, SC, TN, TX, VA.
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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