Technological Medical Advancements Llc: Lamp, Infrared, Therapeutic Heating
- Recalling firm
- Technological Medical Advancements LLC
- Product
- 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
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-01-09
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide distribution in the states of TX, CA, MI, MD, PA, FL, MN, DC, MI.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/4c4f8ed9-bc02-4d78-9fc4-5c4de0f2f4d5