Z-0480-2026 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- November 19, 2025
- Initiation Date
- October 7, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 236 units
Product Description
GM85 Digital Mobile X-ray imaging System; Model Number: GM85;
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.
Distribution Pattern
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,
Code Information
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;