Diowave Laser System, REF: Diowave 250W
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.
Quick Facts at a Glance
- Recall Date
- January 9, 2026
- Hazard Level
- HIGH
- Brand
- Technological Medical Advancements
- Geographic Scope
- 1 states
Hazard Information
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.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Technological Medical Advancements LLC or your healthcare provider for instructions. Notification method: Letter
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Full Description
Diowave Laser System, REF: Diowave 250W. Reason: 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.. Classification: Class II. Quantity: 16. Distribution: US Nationwide distribution in the states of TX, CA, MI, MD, PA, FL, MN, DC, MI.
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