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 |
Code Information |
Serial Numbers: 5143M3IJ100002P 5143M3IJ100010M 5143M3IJ600013B 5143M3HJ500001Y 5143M3IK400005T 513YM3IK100001A 5143M3IJ600014H 5143M3JK400005Y 5143M3IJ400007P 5143M3HK400003P 52VUM3IKA00008M 513YM3IJA00001X 5143M3JJ400007E 5143M3JJ400006K 52VUM3HK800003X 52VUM3IKA00009W 5143M3JJ300001K 5143M3HJ600003K 5143M3JJ300002X 5143M3JJ300003J 5143M3IJ800008L 5143M3IK400003Z 5149M3IK400001H 5149M3IK400002K 5143M3HK400002V 52VUM3IKA00016E 5143M3HK300004E 514GM3HK100005L 5143M3JK100012J 5143M3IJC00001Y 5143M3JK100003Z 5143M3JK100002B 5143M3HK600006E 5143M3IK400002J 514GM3HK100002R 5143M3HK300007N 52VUM3HK800002F 5143M3HK300010P 52VUM3IK800004K 5143M3IJ100005R 5143M3IK300002J 5143M3HJA00002K 514GM3IK400001L 5143M3JJ200011L 5143M3JJ300012N 5143M3IJ600007N 5143M3IHC00003Y 5143M3IHC00004N 5143M3IHC00015L 5143M3IHC00013X 5143M3DHB00001M 5143M3IHC00014H 5143M3RJ100002V 5143M3JJ200004Y 5143M3JJ200005X 5143M3JK400008N 5143M3JK100015B 5143M3HJA00006P 5143M3JJ200012Z 5143M3IK600005J 5143M3JK400013K 5143M3JJ700004K 5143M3IHC00012Z 514GM3JK300001A 514GM3HK600001T 5143M3IJ800011E 5143M3IK300008R 5143M3IHC00019T 5143M3IJ100001Y 5143M3JK400009V 5143M3HK300017E 5143M3IJ100003X 5143M3HK300001F 5143M3HJA00010W 5143M3JJC00004Y 5143M3GK500006P 5143M3IK400004F 513YM3IK400001W 5143M3JK400007B 5143M3JK400004M 5143M3JK400006R 5143M3IHC00008E 5143M3JJ200016T 5143M3IJ800013Y 5143M3JK100006N 5143M3JK400014E 5143M3IJ600011M 5143M3IJ300004W 5143M3RJ100001M 5143M3JJ200014F 5143M3JJ200017Y 5143M3IJ400003R 5143M3IJ400004B 5143M3HJ900003W 5143M3HJ900002V 5143M3IJ200002F 5143M3IJ600008K 5143M3JJ300011Z 5143M3HJ900006H 5143M3JJ200001F 5143M3JJ200002M 5143M3HJA00004Y 5143M3HJA00005A 5143M3HJ900004M 5143M3HJA00007D 5143M3GK500002Y 5143M3JJ400002X 5143M3HJ500005P 5143M3HJ500006W 5143M3IJ600006W 5143M3HJ900005J 514GM3HK100001E 5143M3HK300018W 5143M3JJ700003D 5143M3JJ700002R 5143M3JK100014L 5143M3HK300006Z 5143M3JJ700005W 5143M3IJ800001B 5143M3IJ800002V 5143M3IJ800005X 5143M3IJ800003J 5143M3IJ800004F 5143M3JJ700001V 5143M3HK200005V 5143M3GK500004A 5143M3IJ200001D 5143M3HK400007T 52VUM3IK800001F 5143M3IJ100011V 5143M3IK400009H 5143M3IK400010R 5143M3JK500003W 5143M3JK500002P 5143M3JK500005V 5143M3JK500007L 5143M3HK600001D 5143M3IK600003N 5143M3IK600001Y 5143M3IK600004K 5143M3HJ600005D 513YM3IK500003Z 5143M3IK400007W 5143M3GK500003J 5143M3JJC00001X 5143M3HK200006K 5143M3HK200004H 5143M3HK300011R 513YM3IK500001K 513YM3IK500004H 5143M3IJ100012T 5143M3JJ200015M 5143M3HJ500004M 5143M3IJ600004F 5143M3IJ800007K 5143M3IJ600005Y 5149M3IK400003E 5143M3HK700005P 5143M3HK700003W 5143M3JJ300008P 5143M3GK500008D 5143M3IJ100004E 5143M3RJ100003T 5143M3IJ800014B 5143M3HJ900009E 5143M3IHC00002L 5143M3IK300001X 5143M3JK100008H 5143M3HK300003Y 5143M3JK400003D 5143M3IK400006X 5143M3IJ600001H 5143M3HJA00008X 5143M3HK400009W 5143M3JK100007F 5143M3IJ800009M 5143M3IJ400005N 5143M3IJ200003M 5143M3IJ400006V 513YM3IK500005Y 5143M3IK300006T 513YM3IK400002A 513YM3IK100002D 513YM3IK100003N 5143M3HJ900001L 5143M3HK400004J 5143M3IHC00011V 5143M3JK400011A 5143M3IJB00003H 5143M3IK400008A 5143M3IHC00001H 5143M3IHC00010R 5143M3JJ200018X 5143M3GK500005M 5143M3IJ800012D 5143M3JJ400005H 5143M3HJ900010Z 5143M3JJC00002H 5143M3HK300012L 5143M3JJ200008B 52VUM3IKA00015N 5143M3IHC00006T 5143M3JJ400001T 5143M3IJ600003L 5143M3JJ200010J 5143M3HJ500002J 5143M3IJ600002P 5143M3HJ500003A 5143M3HJA00003Z 5143M3IJC00002N 5143M3HJA00001B 5143M3IK400001P 5143M3HK300013A 5143M3JK100001L 5143M3IHC00009M 5143M3IJ300002Y 5143M3IJ300006N 5143M3JK400012H 5143M3HK400008X 5143M3IJ600012X 5143M3HJ900008F 5143M3GK500007W 5143M3GK500001H 513YM3IK500002R 5143M3HK400006F 5143M3JJ300006H 5143M3JJ300007T 5143M3JK100004A 514GM3HK100003J 5143M3IJ300003E 5143M3JJC00003L 5143M3JJB00001F 5143M3HJ900007R 5143M3IJ600010Z 5143M3HJA00009N 5143M3JK100013W 5143M3IK500001F 5143M3JJ500002M 5143M3IHC00017N 5143M3IHC00016Y 5143M3JK500004D 5143M3HK600004A 5143M3IJ600009J 5143M3IHC00005J 5143M3IJ100013K 52VUM3IKA00013D 52VUM3IKA00017F 5143M3IK300005H 5143M3IK300007P 5143M3HK300009K 5143M3IJ800010H 5143M3JK100009M 5143M3HK400010M 5143M3JJ300010W 5143M3HK600009X 5143M3HK600011N 5143M3HK600002T 5143M3IK600002W 5143M3HK600005V 5143M3HK600008M 5143M3JK500001M 5143M3JK500006X 5143M3IK600006D 5143M3JK100010E 5143M3JK100011R 5143M3JK100005D 52VUM3IK800002X 5143M3JJC00005N 5143M3JJC00006J 514GM3HK100004W 5143M3HK400005Z 5143M3HK300008M 5143M3IJ100006J 5143M3IJ100009B 5143M3HK600003R 5143M3HK300005W 5143M3IJ300005Z 5143M3IHC00007A 52VUM3IKA00007J 52VUM3IKA00005R 5143M3JJ200013D 5143M3IJ600015P 5143M3HK300002V 5143M3JJ200009A 5143M3IHC00018J 5143M3JJ200007W 514GM3JJ900001R 5143M3HJ600004J |
Recalling Firm/ Manufacturer |
NeuroLogica Corporation 14 Electronics Ave Danvers MA 01923-1011
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = IZL
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