Z-2162-2026 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- May 20, 2026
- Initiation Date
- January 9, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 16
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.
Distribution Pattern
US Nationwide distribution in the states of TX, CA, MI, MD, PA, FL, MN, DC, MI.
Code Information
UDI-DI: G180DIOWAVESTEALTHMAX0. All software versions prior to, but not including V1.81