GM85 Digital Mobile X-ray imaging System; Model Number: GM85;
| Source | FDA Device Enforcement |
|---|---|
| Category | Medical Device |
| Severity | Medium |
| Status | ongoing |
| Recall date | October 07, 2025 |
| Reported | November 19, 2025 |
| Recalling firm | NeuroLogica Corporation |
| Country / region | United States MA |
Hazard
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.
Affected products
- GM85 Digital Mobile X-ray imaging System; Model Number: GM85;
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