Recall Z-0480-2026 ยท IZL System, X-Ray, Mobile
NeuroLogica Corporation
GM85 Digital Mobile X-ray imaging System; Model Number: GM85;
| Date | Nov 7, 2025 (initiated Oct 7, 2025) |
| Status | Open, Classified |
| 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. |
| Root cause | Device Design |
| Action | On October 7, 2025, "URGENT MEDICAL DEVICE CORRECTION" letters were sent to customers. The letters described the problem, product and actions to be taken. The customers were instructed to take the following Actions: Users may continue to use the GM85 system. Customers can inspect the unit for missing or loose bolts and if any issues with the bolts are detected, then please contact the service engineer immediately for inspection. This notice needs to be passed on all those who need to be aware within your organization or to any organization where the potentially affected devices have been trans |
| 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 Ara |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K222353 | GM85 Samsung Electronics Co., Ltd., Sep 29, 2022 |