Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2162-2026 — Diowave Laser System, REF: Diowave 250W

U.S. FDA — Device Enforcement · United States · 2026-01-09 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2162-2026
Date of alert
2026-01-09
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Technological Medical Advancements LLC
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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