Warning
Technological Medical Advancements LLC Recalls Diowave Laser System
This is a Class II recall. This product may cause temporary health problems or pose a slight threat of a serious nature.
Source: FDA
WarningRecall #Z-2162-2026Medical Device
Technological Medical Advancements LLC Recalls Diowave Laser System
Technological Medical Advancements LLC · Class II — Moderate Risk
Product Description
Diowave Laser System, REF: Diowave 250W
Reason for Recall
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.
FDA Classification
Class II — Moderate Risk
A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Distribution
US Nationwide distribution in the states of TX, CA, MI, MD, PA, FL, MN, DC, MI.
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
Sources: FDA openFDA Enforcement Database