GM85 Digital Mobile X-ray imaging System; Model Number: GM85;
FDA device recall Z-0480-2026 · posted 2025-11-07 · Open, Classified
Recall details
- Recalling firm
- NeuroLogica Corporation
- 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.
- Action taken
- 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 transferred. Please transfer this notice to other organizations on which this action has an impact. Please maintain awareness on this notice and resulting action for an appropriate period to ensure effectiveness of the corrective action. Complete and return the Customer Reply Form (CRF) Samsung Electronics will undertake the voluntary corrective action to reinforce the arm with a high tensile bolt to eliminate the risk of the THU falling and preventing any potential risk of injury. Service engineers will correct all affected devices free of charge and contact you to arrange for the correction. All corrections in the field started in September 2025 and will be completed by June 2026. If you have any questions, contact VP via email: ngujar@neurologica.com or call 978-564-8632.
- Root cause
- Device Design
- Status
- Open, Classified
- Product code
- IZL
- Quantity affected
- 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,
- Date initiated
- 2025-10-07
- Date posted
- 2025-11-07
- Location
- Danvers, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GM85 (K222353) | Samsung Electronics Co., Ltd. | 2022-09-29 |