Diowave Laser System, REF: Diowave 250W

FDA device recall Z-2162-2026 · posted 2026-05-11 · Open, Classified

Recall details

Recalling firm

Technological Medical Advancements LLC

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.

Action taken

Starting on 1/9/2026, customer notifications were sent informing customers to install software update V1.81. On 3/11/2026, correction notices were sent to customers informing them to take the following actions: 1) Install Software Update V1.81. Follow the WiFi upgrade instructions to complete the update. The update is free of charge and requires no hardware modifications. 2) Confirm Completion. Once the update is installed, please complete and return the enclosed Correction Response Form by email to info@diowavelaser.com. Alternatively, mail the completed form to TMA at the address above. 3) Forward This Notice. This notice must be passed on to all persons within your organization who need to be aware of this correction, and to any organization where the affected device has been transferred or is currently in use. 4) Contact Support If Needed. Firm's technical support team is available Monday through Friday, 9:00 AM 5:00 PM ET, at (561) 722-1153 or info@diowavelaser.com

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

ILY

Quantity affected

16

Distribution

US Nationwide distribution in the states of TX, CA, MI, MD, PA, FL, MN, DC, MI.

Date initiated

2026-01-09

Date posted

2026-05-11

Location

West Palm Beach, FL

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