Z-0480-2026Class II

GM85 Digital Mobile X-ray imaging System; Model Number: GM85

Name: Z-0480-2026 GM85 Digital Mobile X-ray imaging System; Model Number: GM85
Creator: NeuroLogica Corporation
Published: 2025-10-07
License: https://open.fda.gov/license/

Samsung HME America, Inc. / initiated 2025-10-07 / Open, Classified / root cause: design

FDA source

NeuroLogica Corporation began a recall of GM85 Digital Mobile X-ray imaging System; Model Number: GM85 on 2025-10-07. FDA classified it as Class II and gives the reason as "The four (4) M5 bolts that secure the Tube Head Unit to the end of the arm may loosen or fracture due to metal fatigue". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0480-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-10-07
Posted: 2025-11-07
Recalling firm: Samsung HME America, Inc.
Product: GM85 Digital Mobile X-ray imaging System; Model Number: GM85;
Product code: IZL System, X-Ray, Mobile
Reason for recall: The four (4) M5 bolts that secure the Tube Head Unit to the end of the arm may loosen or fracture due to metal fatigue.
Root cause tag: design
FDA root cause: Device Design
Action: On October 7, 2025, "URGENT MEDICAL DEVICE CORRECTION" letters were sent to customers. The letters described the problem, product and actions to be taken. The customers were instructed to take the following Actions: Users may continue to use the GM85 system. Customers can inspect the unit for missing or loose bolts and if any issues with the bolts are detected, then please contact the service engineer immediately for inspection. 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. Please transfer this notice to other organizations on which this action has an impact. Please maintain awareness on this notice and resulting action for an appropriate period to ensure effectiveness of the corrective action. Complete and return the Customer Reply Form (CRF) Samsung Electronics will undertake the voluntary corrective action to reinforce the arm with a high tensile bolt to eliminate the risk of the THU falling and preventing any potential risk of injury. Service engineers will correct all affected devices free of charge and contact you to arrange for the correction. All corrections in the field started in September 2025 and will be completed by June 2026. If you have any questions, contact VP via email: [email protected] or call 978-564-8632.
Quantity in commerce: 236 units
Distribution: Domestic: US Nationwide Distribution. International: Australia, Belgium, Canada, Chile, China Mainland, Czech Republic, Denmark, Ecuador, Finland, France, Germany, GHANA, Hungary, India, Italy, Korea, Malaysia, Mexico, Netherlands, New Zealand, Norway, Peru, Philippines, Poland, Portugal, Saudi Arabia, Serbia, Singapore, Spain, Sweden, Switzerland, Thailand, T¿rkiye, United Kingdom, Utd.Arab Emir., Vietnam,
Product codes and lots: Model Number: GM85; UDI-DI: 08806088582412; Serial Numbers: 514GM3IK400001L, 5143M3IK300001X, 5143M3IJ100010M, 5143M3IHC00014H, 5143M3IK300008R, 5143M3JJ400007E, 5143M3HJ900002V, 5143M3IK400004F, 513YM3IK500003Z, 5143M3HK600005V, 5143M3JJ200010J, 5143M3HK600008M, 5143M3HK200004H, 5143M3JK500003W, 5143M3IJ200002F, 5143M3IHC00007A, 5143M3JJ300001K, 5143M3IJ600014H, 5143M3JK500006X, 5143M3JJ200017Y, 5143M3JK400014E, 5143M3IJ600013B, 5143M3GK500004A, 5143M3IHC00011V, 5143M3JK500001M, 5143M3JJ300012N, 5143M3GK500005M, 5143M3IK400007W, 5143M3JK400008N, 5143M3JJ300011Z, 5143M3JK100003Z, 5143M3JK500007L, 5143M3IK500001F, 5143M3IHC00002L, 5143M3IK300006T, 5143M3IHC00010R, 5143M3IK600004K, 5143M3IJ300003E, 5143M3IHC00003Y, 5143M3JJ400006K, 5143M3HJ900001L, 5143M3IJ600003L, 5143M3IJC00001Y, 5143M3IJ600001H, 5143M3HJ500003A, 5149M3IK400003E, 5143M3IJ800008L, 5143M3JJ700002R, 5143M3HK300002V, 5143M3JJ200008B, 513YM3IK500002R, 5143M3JK100005D, 5143M3IJ600004F, 5143M3IHC00005J, 5143M3JJC00004Y, 5143M3HK600003R, 5143M3JK500004D, 5143M3HK600004A, 5143M3HK300012L, 5143M3HK300008M, 5143M3JJ200015M, 5143M3HK300007N, 5143M3JK100007F, 5143M3IHC00001H, 5143M3IJ400006V, 5143M3IJ100002P, 514GM3HK100003J, 5143M3HK600010W, 5143M3HJ500001Y, 5143M3JK400010W, 5143M3IJ300005Z, 5143M3HK400010M, 5149M3IK400002K, 5143M3IK400002J, 5143M3GK500007W, 5143M3IK400009H, 5143M3IJ300002Y, 5143M3JK100004A, 513YM3IK400001W, 5143M3HK600011N, 5143M3HK300003Y, 5143M3JJ200012Z, 5143M3JK400007B, 5143M3HJA00002K, 5149M3IK400001H, 5143M3IJ100005R, 5143M3IHC00012Z, 5143M3HK400009W, 514GM3HK100002R, 5143M3IJ100001Y, 5143M3HK700002K, 5143M3IJ400004B, 5143M3JK400004M, 5143M3HJ900006H, 5143M3HK300005W, 5143M3JJ700001V, 5143M3IJ600015P, 5143M3JJ500002M, 5143M3HJ900003W, 5143M3IK600001Y, 5143M3JK100015B, 5143M3HJ600003K, 5143M3IJ200001D, 5143M3RJ100001M, 5143M3HK600009X, 5143M3IK600003N, 5143M3JJ300007T, 5143M3IJ400003R, 5143M3IK600002W, 5143M3HK200006K, 5143M3HJ900007R, 5143M3JK100002B, 5143M3IJ300006N, 5143M3IHC00017N, 5143M3IK300009L, 5143M3IJ500001B, 5143M3JJC00003L, 5143M3HJ500004M, 5143M3JK100006N, 5143M3HK700001D, 514GM3JK300001A, 5143M3IJ800005X, 5143M3HK400003P, 5143M3IK400005T, 5143M3HK300009K, 5143M3IJ600012X, 5143M3IHC00015L, 5143M3HK300010P, 5143M3RJ100003T, 5143M3DHB00001M, 5143M3IJ100003X, 5143M3IJ600006W, 5143M3IK400008A, 5143M3IHC00019T, 5143M3JK100014L, 513YM3IK400002A, 513YM3IK500005Y, 5143M3JK500002P, 5143M3HK400004J, 5143M3HJ500002J, 5143M3IJ400005N, 5143M3JJ400002X, 5143M3JJ200014F, 5143M3JJ700004K, 5143M3HK300017E, 5143M3IJ800011E, 5143M3HK300013A, 5143M3HK600007Z, 5143M3HK300004E, 5143M3GK500003J, 5143M3GK500001H, 5143M3GK500002Y, 5143M3GK500006P, 5143M3HK600002T, 5143M3HK600001D, 5143M3JK400013K, 5143M3HK400006F, 5143M3HK400007T, 5143M3HK400005Z, 5143M3HK400008X, 5143M3JK500005V, 513YM3IK500001K, 513YM3IK500004H, 5143M3HK300019Z, 5143M3JK400011A, 5143M3JK400003D, 5143M3JK400006R, 5143M3JK400009V, 5143M3JK400012H, 5143M3IK400003Z, 5143M3IK400006X, 5143M3HK300016Y, 5143M3IK300005H, 5143M3IK300007P, 5143M3HK300006Z, 5143M3HK300001F, 5143M3IK300002J, 5143M3HK200005V, 513YM3IK100002D, 513YM3IK100003N, 5143M3JK100013W, 514GM3HK100001E, 514GM3HK100004W, 5143M3JK100009M, 5143M3JK100008H, 5143M3JJC00006J, 5143M3JJC00002H, 5143M3HJA00010W, 5143M3HJA00008X, 513YM3IJA00001X, 5143M3HJA00007D, 5143M3HJA00001B, 5143M3HJ900010Z, 5143M3HJ900009E, 5143M3IJ800012D, 5143M3IJ800014B, 5143M3IJ800009M, 5143M3IJ800013Y, 514GM3JJ900001R, 5143M3IJ800007K, 5143M3IJ800001B, 5143M3IJ800002V, 5143M3IJ800003J, 5143M3IJ800004F, 5143M3JJ700003D, 5143M3JJ700005W, 5143M3HJ600005D, 5143M3IJ600009J, 5143M3IJ600008K, 5143M3IJ600007N, 5143M3IJ600005Y, 5143M3IJ600011M, 5143M3HJ500006W, 5143M3IJ600002P, 5143M3IJ400007P, 5143M3JJ400005H, 5143M3IJ300004W, 5143M3JJ300009R, 5143M3JJ300004B, 5143M3JJ300005D, 5143M3JJ200018X, 5143M3JJ300002X, 5143M3JJ300003J, 5143M3JJ200013D, 5143M3JJ200011L, 5143M3JJ200002M, 5143M3JJ200005X, 5143M3JJ200009A, 5143M3JJ200006R, 5143M3RJ100002V, 5143M3IJ100011V, 5143M3IJ100004E, 5143M3IHC00016Y, 5143M3IHC00009M, 5143M3IHC00008E, 5143M3IHC00006T;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0480-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0480-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-11-19	2025-11-07

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)