Official recall notice
FDA DeviceClass IINotable
Diowave Laser System Recall (May 2026)
Product: Diowave Laser System, REF: Diowave 250W
- Recall date
- 2026-05-20
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
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.
Product description
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.