Samsung Digital Diagnostic Mobile X-ray System, Model GM85.
FDA Device Recall #Z-1056-2024 - Class II, December 28, 2023
Recall Summary
| Recall Number | Z-1056-2024 |
| Classification | Class II - Moderate risk |
| Date Initiated | December 28, 2023 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | NeuroLogica Corporation |
| Location | Danvers, MA |
| Product Type | Devices |
| Quantity | 261 devices |
Product Description
Samsung Digital Diagnostic Mobile X-ray System, Model GM85.
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.
Distribution Pattern
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.
Lot / 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.
Other Recalls from NeuroLogica Corporation
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0480-2026 | Class II | GM85 Digital Mobile X-ray imaging System; Mode... | Oct 7, 2025 |
| Z-2715-2024 | Class II | GM60A. Digital Diagnostic Mobile X-Ray System. | Jul 8, 2024 |
| Z-2068-2023 | Class II | OmniTom/OmniTom Elite- X-ray computed tomograph... | Jun 6, 2023 |
| Z-1414-2023 | Class II | Samsung GM85 Digital X-ray Imaging System-A Dig... | Mar 8, 2023 |
| Z-2772-2020 | Class II | OmniTom Computed tomography x-ray system, Model... | Jul 15, 2020 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic, removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency, Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.