United StatesThe Diowave Laser System, REF: Diowave 250W (UDI-DI: G180DIOWAVESTEALTHMAX0), units sold nationwide in TX, CA, MI, MD, PA, FL, MN, DC and listed as 16 units, with all software versions prior to V1.81, is affected. It was recalled because the device can operate at a maximum average power of 70W, exceeding the FDA-cleared 60W, and a software update is needed; owners should install the update.
What's being recalled
Diowave Laser System, REF: Diowave 250W
Recalling firm: Technological Medical Advancements LLC, West Palm Beach, FL, United States.
How to identify it
UDI-DI: G180DIOWAVESTEALTHMAX0. All software versions prior to, but not including V1.81
The 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.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US Nationwide distribution in the states of TX, CA, MI, MD, PA, FL, MN, DC, MI.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)