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U.S. Department of Health and Human Services

Class 2 Device Recall GM85

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  Class 2 Device Recall GM85 see related information
Date Initiated by Firm May 06, 2019
Create Date May 30, 2019
Recall Status1 Terminated 3 on June 10, 2020
Recall Number Z-1691-2019
Recall Event ID 82862
510(K)Number K171119  
Product Classification System, x-ray, mobile - Product Code IZL
Product Samsung GM85 Mobile Digital X-ray Imaging System

Product Usage:
The GM85 Digital X-ray imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications
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Recalling Firm/
Manufacturer		 NeuroLogica Corporation
14 Electronics Ave
Danvers MA 01923-1011
Manufacturer Reason
for Recall		 Potential issue related to the operation of the safety latch within the column that supports the arm due to a possibility of potential bodily harm due to a fall of the arm in an unlikely event that the column wire breaks.
FDA Determined
Cause 2		 Process control
Action NeuroLogica Corporation, a subsidiary of Samsung Electronics issued Medical Device Correction Notice on 05/06/19 advising users of the problem, health risk and action to take: Service engineers will correct all affected devices free of charge and contact you to arrange for the correction. All corrections in the field will be completed by September, 2019. Users may continue to use the GM85 system. This notice needs to be passed on all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred.If you need any further information or have any concerns with this issue then please contact your local representative
Quantity in Commerce 288 systems
Distribution US Nationwide Distribution
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 = IZL and Original Applicant = Samsung Electronics Co.,Ltd.
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