{"url_path":"/fda/device/recalls/Z-2162-2026","section_key":"summary","section_title":"DEVICE Recall: Technological Medical Advancements LLC — Diowave Laser System, REF: Diowave 250W","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-01-09","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2162-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"Technological Medical Advancements LLC"},"word_count":117,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2162-2026\n\n**Recalling firm:** Technological Medical Advancements LLC\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-01-09\n**Report date:** 2026-05-20\n\n## Product\nDiowave Laser System, REF: Diowave 250W\n\n## Reason\nSoftware 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.\n\n## Affected lots\nUDI-DI: G180DIOWAVESTEALTHMAX0. All software versions prior to, but not including V1.81\n\n## Distribution\nUS Nationwide distribution in the states of TX, CA, MI, MD, PA, FL, MN, DC, MI."}