Recall archive / FDA device enforcement

Samsung Digital Diagnostic Mobile X-ray System, Model GM85. — FDA record Z-1056-2024

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Dec 28, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product: Samsung Digital Diagnostic Mobile X-ray System, Model GM85.
Reason: Mobile x-ray systems moving arm frame welding issue which presents the potential of bodily harm due to fall of the arm.
Classification: Class II
Recalling firm: NeuroLogica Corporation
Quantity: 261 devices
Agency-reported status: Ongoing
Source record identifier: Z-1056-2024

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	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.

Label field

Details supplied by the agency

Lot, code or applicability

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.

Match all identifying details in the current notice. A brand name alone is not enough.

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.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date: Feb 21, 2024
Recall initiation date: Dec 28, 2023
Center classification date: Feb 9, 2024

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

What the record says

Lot and product identifiers

Distribution

Dates in the source

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