GM85 Digital Mobile X-ray imaging System; Model Number: GM85;
Enforcement
- Recall Number
- Z-0480-2026
- Event ID
- 97721
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- NeuroLogica Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 19, 2025
- Initiation Date
- October 7, 2025
- Classification Date
- November 7, 2025
- Address
- 14 Electronics Ave, Danvers, MA, 01923-1011, United States
Description
GM85 Digital Mobile X-ray imaging System; Model Number: GM85;
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.
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;
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,
236 units