Diowave Laser System, REF: Diowave 250W
| Source | FDA Device Enforcement |
|---|---|
| Category | Medical Device |
| Severity | Medium |
| Status | ongoing |
| Recall date | January 09, 2026 |
| Reported | May 20, 2026 |
| Recalling firm | Technological Medical Advancements LLC |
| Country / region | United States FL |
Hazard
Software update is needed for laser systems, for topical infrared heating to provide temporary relief of minor muscle and joint pain, spasms, stiffness associated with minor arthritis, and to temporarily increase local blood circulation, operating at a maximum average power output of 70W, which is beyond the FDA cleared 60W.
Affected products
- Diowave Laser System, REF: Diowave 250W
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