FDA Medical Device Recalls (openFDA)
Technological Medical Advancements LLC: Diowave Laser System, REF: Diowave 250W
- Recall number
- Z-2162-2026
- Recalling firm
- Technological Medical Advancements LLC
- Product
- Diowave Laser System, REF: Diowave 250W
- Status
- Open, Classified
- Initiated
- 2026-01-09
- Posted
- 2026-05-11
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Under Investigation by firm
- Action
- 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
- Quantity
- 16
- Distribution
- US Nationwide distribution in the states of TX, CA, MI, MD, PA, FL, MN, DC, MI.
- Lot, serial or model codes
- UDI-DI: G180DIOWAVESTEALTHMAX0. All software versions prior to, but not including V1.81
- 510(k) numbers
- ["K121363"]
- PMA numbers
- not on file
- Product code
- ILY
- Firm FEI
- 3009346095
- Firm city
- West Palm Beach
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28