GM85 Digital Mobile X-ray imaging System; Model Number: GM85;
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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;
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- NeuroLogica Corporation
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
GM85 Digital Mobile X-ray imaging System; Model Number: GM85;
Product Codes/Lot Numbers:
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;
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0480-2026
Related Recalls
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NeuroLogica
Potential for the anti-fall system of the device arm to fail.
Mobile x-ray systems moving arm frame welding issue which presents the potential of bodily harm due to fall of the arm.
1. Wheels loosening over time with use of the device could lead to the inability to effectively drive the device and could lead to delay in patient treatment. 2.Batteries used to power the NL5000 device contain contaminated boards, which may impact the ability to power on the device, this could lead to delay for patient treatment