Recall Z-2162-2026 ยท ILY Lamp, Infrared, Therapeutic Heating
Technological Medical Advancements LLC
Diowave Laser System, REF: Diowave 250W
| Date | May 11, 2026 (initiated Jan 9, 2026) |
| Status | Open, Classified |
| 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) |
| Quantity | 16 |
| Distribution | US Nationwide distribution in the states of TX, CA, MI, MD, PA, FL, MN, DC, MI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K121363 | DIOWAVE LOW LEVEL COLD LASER SYSTEM Technological Medical Advancments, Inc. (Tma), Nov 23, 2012 |