Z-2162-2026Class II

Diowave Laser System, REF: Diowave 250W

Name: Z-2162-2026 Diowave Laser System, REF: Diowave 250W
Creator: Technological Medical Advancements LLC
Published: 2026-01-09
License: https://open.fda.gov/license/

Technological Medical Advancements LLC / initiated 2026-01-09 / Open, Classified / root cause: software

FDA source

Technological Medical Advancements LLC began a recall of Diowave Laser System, REF: Diowave 250W on 2026-01-09. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-2162-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-01-09
Posted: 2026-05-11
Recalling firm: Technological Medical Advancements LLC
Product: Diowave Laser System, REF: Diowave 250W
Product code: ILY Lamp, Infrared, Therapeutic Heating
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.
Root cause tag: software
FDA 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 [email protected]. 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 [email protected]
Quantity in commerce: 16
Distribution: US Nationwide distribution in the states of TX, CA, MI, MD, PA, FL, MN, DC, MI.
Product codes and lots: UDI-DI: G180DIOWAVESTEALTHMAX0. All software versions prior to, but not including V1.81

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2162-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2162-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-05-20	2026-05-11

Product code ILY

K121363Class IIDiowave Low Level Cold Laser SystemTechnological Medical Advancments, Inc. (Tma) / cleared 2012-11-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)