FDA DeviceClass IINotable
FDA Recall: Diowave Laser System, REF: Diowave 250W
Description
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.
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.
Remedy
16
Related Recalls
2026-07-01 · FDA_DEVICE
FDA Recall: Thuvera Laser Console. Software Version 2.2. Portable Thulium Fiber Laser.
IPG Medical Corporation
2026-07-01 · FDA_DEVICE
FDA Recall: Medline Convenience Kits: 1) DRAWER 6A ADULT CENTRAL LINE, Model Number: ACC010890; 2) OPEN HEAR
Medline Industries, LP
2026-07-01 · FDA_DEVICE
FDA Recall: Surgify Halo, 4.0 mm, Short, Model/Catalog Number: 40.125.NVG.H1; drills, burrs, trephines & accesso
SURGIFY MEDICAL OY
2026-07-01 · FDA_DEVICE
FDA Recall: Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. KIT NEURO CSTM
Medline Industries, LP