Z-1056-2024Class II

Samsung Digital Diagnostic Mobile X-ray System, Model GM85

Name: Z-1056-2024 Samsung Digital Diagnostic Mobile X-ray System, Model GM85
Creator: NeuroLogica Corporation
Published: 2023-12-28
License: https://open.fda.gov/license/

Samsung HME America, Inc. / initiated 2023-12-28 / Open, Classified / root cause: manufacturing process

FDA source

NeuroLogica Corporation began a recall of Samsung Digital Diagnostic Mobile X-ray System, Model GM85 on 2023-12-28. FDA classified it as Class II and gives the reason as "Mobile x-ray systems moving arm frame welding issue which presents the potential of bodily harm due to fall of the arm". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1056-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-12-28
Posted: 2024-02-09
Recalling firm: Samsung HME America, Inc.
Product: Samsung Digital Diagnostic Mobile X-ray System, Model GM85.
Product code: IZL System, X-Ray, Mobile
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.
Root cause tag: manufacturing process
FDA root 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 [email protected]. Contact your local representative with questions email: [email protected], 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1056-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1056-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-21	2024-02-09

Product code IZL

K222353Class IIGm85Samsung Electronics Co., Ltd. / cleared 2022-09-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)