Notice names this product. Technological Medical Advancements’s Diowave Laser System is named in FDA Class II recall Z-2162-2026.
Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies.Agency-reported 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. Identifying details: UDI-DI: G180DIOWAVESTEALTHMAX0. All software versions prior to, but not including V1.81. Units affected: 16. Status: Ongoing.
1. Compare your item
This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.
Product named
Diowave Laser System
Company / brand
Technological Medical Advancements
Lot / serial / date codes
UDI-DI: G180DIOWAVESTEALTHMAX0. All software versions prior to, but not including V1.81
Distribution
US Nationwide distribution in the states of TX, CA, MI, MD, PA, FL, MN, DC, MI.
Agency product description and boundaries
Diowave Laser System, REF: Diowave 250W
Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.
If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.
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 arthri…