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U.S. Department of Health and Human Services

Class 2 Device Recall Discovery NM/CT 670 DR

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  Class 2 Device Recall Discovery NM/CT 670 DR see related information
Date Initiated by Firm May 24, 2018
Create Date December 13, 2018
Recall Status1 Completed
Recall Number Z-0606-2019
Recall Event ID 81680
510(K)Number K093514  
Product Classification System, tomography, computed, emission - Product Code KPS
Product Discovery NM/CT 670 DR, model 5376204-70-56 intended for use in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer.
Code Information GTIN 00840682124393 Serial Numbers: DDRW34032, DDRX34038, DDRX34041, DDRX34045 
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		 When your system was installed, the Main disconnect switch, EPO button on the A1 panel, and Remote EPO button(s) (outside of the A1 panel) may not have been wired correctly which could result in these not shutting off all power to the entire system as intended, resulting in a potential electric hazard.
FDA Determined
Cause 2		 Component change control
Action The firm initiated the recall by letter on 05/24/2018. The letter explained the issue and requested the UPS(s) be disconnected from the system until the system could be repaired.
Quantity in Commerce 4 units
Distribution CA, DC, OH, UT, WI, Canada
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.
510(K) Database 510(K)s with Product Code = KPS and Original Applicant = GE MEDICAL SYSTEMS F.I. HAIFA
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