Company: Technological Medical Advancements LLC
Date of Enforcement Report: 5/11/2026
Class: II
PRODUCT
Diowave Laser System, REF: Diowave 250W
Recall Number:
Z-2162-2026
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.
RECALLING FIRM/MANUFACTURER:
Technological Medical Advancements LLC
VOLUME:
16
DISTRIBUTION:
US Nationwide distribution in the states of TX, CA, MI, MD, PA, FL, MN, DC, MI.
