GM85 Digital Mobile X-ray imaging System recall
GM85 Digital Mobile X-ray imaging System; Model Number: GM85;
Why was GM85 Digital Mobile X-ray imaging System recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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;
- Product
- GM85 Digital Mobile X-ray imaging System; Model Number: GM85;
- Recalling firm
- NeuroLogica Corporation
- Quantity
- 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,
- Recall date
- November 19, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)