FDA DevicesClass II
Diowave Laser System, REF: Diowave 250W
Published: May 20, 2026Recall ID: Z-2162-2026Category: devicesCountry: US
Reason for Recall / Hazard
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.
Product Description & Identification
Diowave Laser System, REF: Diowave 250W
Additional Source Details
| Field | Value |
|---|---|
| City | West Palm Beach |
| State | FL |
| Event id | 98507 |
| Address 1 | 1601 Belvedere Rd Ste E-180 |
| Code info | UDI-DI: G180DIOWAVESTEALTHMAX0. All software versions prior to, but not including V1.81 |
| Postal code | 33406-1541 |
| Report date | 20260520 |
| Product type | Devices |
| Product quantity | 16 |
| 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260109 |
| Initial firm notification | Letter |
| Center classification date | 20260511 |
Overview
- Recalling FirmTechnological Medical Advancements LLC
- StatusOngoing
- Risk LevelClass II
- DistributionUS Nationwide distribution in the states of TX, CA, MI, MD, PA, FL, MN, DC, MI.