NeuroLogica Corporation: Device Recall
Recall #Z-0480-2026 · 10/07/2025
Class II: Risk
Recall Details
- Recall Number
- Z-0480-2026
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- NeuroLogica Corporation
- Status
- Ongoing
- Date Initiated
- 10/07/2025
- Location
- Danvers, MA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 236 units
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.
Product Description
GM85 Digital Mobile X-ray imaging System; Model Number: GM85;
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,
Other Recalls by NeuroLogica Corporation
- Class II: Risk 07/08/2024
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.