Class 2 Device Recall GM85

• Date Initiated by Firm: December 28, 2023
• Date Posted: February 09, 2024
• Recall Status: Open, Classified
• Recall Number: Z-1056-2024
• Recall Event ID: 93803
• 510(K)Number: K222353
• Product Classification: System, x-ray, mobile - Product Code IZL
• Product: Samsung Digital Diagnostic Mobile X-ray System, Model GM85.
• Code Information: UDI-DI: 08806088582412, serial numbers: 5143M3HK400010M, 5143M3IJ800012D, 5143M3IK400005T, 5149M3IK400001H, 5149M3IK400002K, 5143M3IK400003Z, 5143M3GK500001H, 513YM3IK100001A, 5143M3HJ500001Y, 5143M3IJ600014H, 5143M3HK400002V, 5143M3JK400005Y, 5143M3HJ900001L, 5143M3IJ400007P, 5143M3HK400007T, 5143M3HK400003P, 513YM3IJA00001X, 5143M3JJ400007E, 5143M3IJ400006V, 5143M3JJ400006K, 5143M3JK400009V, 5143M3IJ200001D, 5143M3JJC00004Y, 5143M3JJ200017Y, 5143M3IHC00009M, 5143M3IJ100011V, 5143M3JJ300001K, 5143M3HJ600003K, 5143M3IK300002J, 5143M3JJ300003J, 5143M3JJ300002X, 5143M3JK400011A, 5143M3HK300016Y, 5143M3IJ800008L, 5143M3IJ600013B, 5143M3IJ100010M, 5143M3IJ100002P, 5143M3HK300011R, 5143M3HK200004H, 5143M3HK200006K, 5143M3JJC00001X, 5143M3IJ100009B, 5143M3IJ100006J, 5143M3HK300017E, 5143M3JK400006R, 5143M3JK400007B, 5143M3JK400004M, 5143M3HK300004E, 5143M3IJ600011M, 5143M3JK100012J, 514GM3HK100005L, 5143M3JK100003Z, 5143M3JK100002B, 5143M3IJC00001Y, 5143M3IK400002J, 5143M3IK400001P, 5143M3HK300007N, 514GM3HK100002R, 5143M3HK300010P, 5143M3HJA00002K, 514GM3IK400001L, 5143M3JJ200011L, 5143M3JJ300012N, 5143M3RJ100001M, 5143M3IJ600007N, 5143M3IHC00015L, 5143M3IHC00013X, 5143M3IHC00004N, 5143M3IHC00003Y, 5143M3JK400008N, 5143M3JK100015B, 5143M3HJA00006P, 5143M3HJ900007R, 5143M3JJ200012Z, 5143M3IK400008A, 5143M3JK400013K, 5143M3JJ700004K, 5143M3IHC00012Z, 5143M3JJ700001V, 514GM3JK300001A, 5143M3IK300008R, 5143M3IJ100001Y, 5143M3IHC00019T, 5143M3HK300001F, 5143M3HJA00010W, 5143M3IHC00018J, 513YM3IK400001W, 5143M3IJ100003X, 5143M3HK400009W, 5143M3JJ500002M, 5143M3IHC00008E, 5143M3HK300019Z, 5143M3JJ200016T, 5143M3JK400010W, 5143M3IJ800013Y, 5143M3JK500001M, 5143M3JK500006X, 5143M3JK100006N, 5143M3IJ300004W, 5143M3JJ200014F, 5143M3HJ900003W, 5143M3HJ900002V, 5143M3IJ400003R, 5143M3IJ400004B, 5143M3JJ200005X, 5143M3JJ200004Y, 5143M3RJ100002V, 5143M3IHC00014H, 5143M3IJ600008K, 5143M3IJ200002F, 5143M3JJ200007W, 5143M3HJ900006H, 5143M3JJ300011Z, 5143M3JJ200002M, 5143M3JJ200001F, 5143M3HJA00005A, 5143M3HJA00004Y, 5143M3GK500002Y, 5143M3HJA00007D, 5143M3HJ900004M, 5143M3HJ900005J, 5143M3IJ600006W, 5143M3HJ500005P, 5143M3HJ500006W, 5143M3JJ400002X, 5143M3DHB00001M, 5143M3HK300018W, 514GM3HK100001E, 5143M3JJ700003D, 5143M3JJ700002R, 5143M3JK100014L, 5143M3HK300006Z, 5143M3IJ800001B, 5143M3IJ800003J, 5143M3IJ800002V, 5143M3IJ800005X, 5143M3IJ800004F, 5143M3JJ700005W, 5143M3IHC00005J, 5143M3JK500007L, 5143M3JK500002P, 5143M3JK500005V, 5143M3JK500003W, 5143M3IK400009H, 5143M3HJ600005D, 513YM3IK500003Z, 5143M3IK400007W, 513YM3IK500001K, 513YM3IK500004H, 5143M3IJ100012T, 5143M3HJ500004M, 5143M3IJ600004F, 5143M3IJ800011E, 5143M3IJ600005Y, 5149M3IK400003E, 5143M3IJ800007K, 5143M3IJ500001B, 5143M3IJ100004E, 5143M3HJ900009E, 5143M3IJ800014B, 5143M3IHC00002L, 5143M3IK300001X, 5143M3HK300003Y, 5143M3JK100008H, 5143M3JJ200015M, 5143M3JK400003D, 5143M3IK400006X, 5143M3IJ100005R, 5143M3IJ600001H, 5143M3JJ200018X, 5143M3HJA00008X, 5143M3JK100007F, 5143M3IJ800009M, 5143M3IJ400005N, 5143M3IJ200003M, 513YM3IK500005Y, 513YM3IK100002D, 513YM3IK400002A, 513YM3IK100003N, 5143M3IK300006T, 5143M3HK400004J, 5143M3IJB00003H, 5143M3IHC00001H, 5143M3JJ200009A, 5143M3HK200005V, 5143M3GK500003J, 5143M3IJ300002Y, 5143M3IJ300006N, 5143M3HJ900008F, 5143M3IHC00011V, 5143M3JJ400005H, 5143M3RJ100003T, 5143M3HJ900010Z, 5143M3JJC00002H, 5143M3HK300012L, 5143M3JJ200008B, 5143M3JJ400001T, 5143M3IHC00006T, 514GM3JJ900001R, 5143M3IJ600003L, 5143M3JJ200010J, 5143M3HJ500003A, 5143M3IJ600002P, 5143M3HJ500002J, 5143M3HJA00003Z, 5143M3IK300009L, 5143M3IJC00002N, 5143M3IK400010R, 5143M3IJ300003E, 5143M3HJA00001B, 5143M3HK400008X, 5143M3JK400012H, 5143M3HK300013A, 5143M3JK100001L, 5143M3IJ600012X, 513YM3IK500002R, 5143M3HK400006F, 5143M3JK400014E, 5143M3JJ300007T, 5143M3JJ300006H, 5143M3IK400004F, 5143M3JK100004A, 514GM3HK100003J, 5143M3JJC00003L, 5143M3JJB00001F, 5143M3HJA00009N, 5143M3IJ600010Z, 5143M3JK100013W, 5143M3IK500001F, 5143M3JJ300008P, 5143M3IHC00017N, 5143M3IHC00016Y, 5143M3JK500004D, 5143M3IJ600009J, 5143M3IJ100013K, 5143M3IK300005H, 5143M3IK300007P, 5143M3HK300009K, 5143M3JK100009M, 5143M3JJ300010W, 5143M3GK500006P, 5143M3JK100010E, 5143M3JK100011R, 5143M3JK100005D, 5143M3IHC00010R, 5143M3JJC00006J, 5143M3JJC00005N, 5143M3JJ300009R, 5143M3HK400005Z, 514GM3HK100004W, 5143M3HK300008M, 5143M3HK300005W, 5143M3JJ300004B, 5143M3JJ300005D, 5143M3JJ200006R, 5143M3IJ300005Z, 5143M3IHC00007A, 5143M3IJ600015P, 5143M3JJ200013D, 5143M3HK300002V, 5143M3HJ600004J.
• Recalling Firm/ Manufacturer: NeuroLogica Corporation; 14 Electronics Ave; Danvers MA 01923-1011
• For Additional Information Contact: Dr. Ninad Gujar; 978-564-8632
• Manufacturer Reason for Recall: Mobile x-ray systems moving arm frame welding issue which presents the potential of bodily harm due to fall of the arm.
• FDA Determined Cause: Process design
• Action: An "Urgent - Medical Device Correction" notice was issued via email on December 28, 2023, cosigned by representatives of Samsung Electronics Co., Ltd. and NeuroLogica Corp. The notice describes the product, problem and actions to taken. The customers were instructed to continue to use the GM85 systems and Service Engineers will contact you to arrange for on-site correction. Share this notice with users within your organization or anywhere the devices may have been transferred. Customer Reply Form are to be completed and returned via email to fsca@neurologica.com. Contact your local representative with questions email: SupportBI@bostonimaging.com, 1-800-976-0980.
• Quantity in Commerce: 261 devices
• Distribution: US Nationwide Distribution including states of: AL, AR, CA, CO, CT, DC, FL, GA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, PA, SD, TN, TX, VA, WI & WV.
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = IZL