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U.S. Department of Health and Human Services

Class 2 Device Recall GC80 Digital Xray Imaging System

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  Class 2 Device Recall GC80 Digital Xray Imaging System see related information
Date Initiated by Firm June 22, 2017
Create Date March 02, 2018
Recall Status1 Terminated 3 on October 05, 2018
Recall Number Z-0726-2018
Recall Event ID 78679
510(K)Number K143029  
Product Classification System, x-ray, stationary - Product Code KPR
Product The GC80 Digital X-ray Imaging System
Code Information Accession Number 1310459
Recalling Firm/
Manufacturer		 NeuroLogica Corporation
14 Electronics Ave
Danvers MA 01923-1011
For Additional Information Contact Giho Kang
978-564-8503
Manufacturer Reason
for Recall		 An image was obtained with over exposure during a Thorax examination using the AEC function.
FDA Determined
Cause 2		 Other
Action On June 22, 2017, Samsung distributed Urgent Field Safety Notices & acknowledgment forms to their customers via email. INSTRUCTIONS FOR END USERS: 1) Please read the Field Safety Notice documentation in detail. 2) Follow the instructions provided in this FSN in relation to any actions which are required of you. 3) Complete the provided acknowledgement form and return to your supplier as soon as possible. Your organizations reply is the evidence we need to monitor the progress of the corrective actions. 4) If required and instructed by this FSN documentation, please undertake all relevant service actions as soon as is practicably possible. INSTRUCTIONS FOR DISTRIBUTORS: 1) Please read the Field Safety Notice documentation in detail. 2) Please review and complete the acknowledgement form provided in this FSN and return to Samsung as soon as possible. Please pass this entire package of FSN documentation onto your customers and ask them to return the completed acknowledgement form. Please forward copies of acknowledgements from end users onto to the email addresses stated above. Samsung require this evidence to monitor the progress of the corrective actions. 4) If required and instructed by this FSN documentation, please undertake all relevant service actions as soon as is practicably possible. Customers with questions were advised to contact their local representative.
Quantity in Commerce 45 units
Distribution Nationwide US
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 = KPR and Original Applicant = SAMSUNG ELECTRONICS CO., LTD.
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