NeuroLogica Corporation recalls GM85 Digital Mobile X-ray imaging System
- Recalling company
- NeuroLogica Corporation
- Product
- GM85 Digital Mobile X-ray imaging System; Model Number: GM85;
- Reason
- 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 II – may cause temporary or medically reversible health consequences
- Recall date
- Oct 7, 2025
- Reported
- Nov 19, 2025
- 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,
- Status
- Ongoing
- Quantity
- 236 units
- Lot / codes
- 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, 5149M3IK4000
- Company location
- Danvers, MA
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-0480-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-0480-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.