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U.S. Department of Health and Human Services

Class 2 Device Recall Samsung GM60A40S

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  Class 2 Device Recall Samsung GM60A40S see related information
Date Initiated by Firm September 14, 2015
Date Posted November 10, 2015
Recall Status1 Terminated 3 on January 19, 2017
Recall Number Z-0263-2016
Recall Event ID 72171
510(K)Number K142492  K150097  
Product Classification System, x-ray, mobile - Product Code IZI
Product Samsung GM60A-40S

Intended for use in generating radiographic images of human anatomy.
Code Information Serial Numbers: 50EAM9BG200004X, 50EAM9BG200001A 50EAM9BG200002P, 50EAM9BG200003D, 50EAM9BG200005N, 50EAM9BG200006E,  50EAM9BG200007F
Recalling Firm/
Manufacturer		 NeuroLogica Corporation
14 Electronics Ave
Danvers MA 01923-1011
For Additional Information Contact Ninad Gujar
978-564-8503
Manufacturer Reason
for Recall		 When the system is driving over a non-conductive floor and then over a conductive, grounded part, proper control of the drive behavior may not be possible. The system can be stopped by releasing the drive handle or by pressing the emergency switch. Proper behavior is re-enabled when the system is rebooted.
FDA Determined
Cause 2		 Device Design
Action An Urgent - Field Safety Notice identifying the affected products, problem involved, root cause, and potential hazards, was sent to customers. In the event the issue occurs, users can release the drive handle or press the emergency switch and the unit will stop. Then, reboot the system. If unintended movements occur, please contact local representative. To correct the issue, service engineers will visit to apply the corrective action. For further information or support concerning this problem, contact local representative.
Quantity in Commerce 7 devices
Distribution Distributed to the states of NC, OH, MA, and MO.
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 = IZI and Original Applicant = SAMSUNG ELECTRONICS CO., LTD.
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