Diowave 250W laser systems with software versions before V1.81 require a software update to meet FDA safety standards for infrared heating therapy. This recall addresses a potential risk of exceeding the 60W power limit.
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.
Diowave Laser System models with software versions prior to V1.81 were recalled because they may exceed the FDA's 60W power limit when used for infrared heating. This could lead to overheating or injury if the device is not updated to the correct software version.
The device's software may allow it to operate at up to 70W, which exceeds the FDA's cleared 60W limit for infrared heating therapy. This could cause overheating or injury if the device is used without the required software update.
Users of Diowave Laser System models with software versions before V1.81 are affected. People using the device for pain relief or muscle therapy are most at risk if the software is outdated.
Check your Diowave Laser System for the software version number. Models with software versions prior to, but not including V1.81 are affected. The device's UDI-DI code is G180DIOWAVESTEALTHMAX0.
Install the latest software version V1.81 or higher to ensure the device operates within the FDA's 60W power limit.
The device may exceed the FDA's 60W power limit when used for infrared heating therapy, which could lead to overheating or injury if the software is outdated.
Software versions prior to, but not including V1.81 are affected.
Check your device's software version number. Models with software versions prior to V1.81 and UDI-DI code G180DIOWAVESTEALTHMAX0 are affected.
We’ve drafted a message you can send Diowave to request your refund or repair — edit it as you like.
Subject: Recall Z-2162-2026 — Diowave Diowave Hello, I own a Diowave that is covered by recall Z-2162-2026 from Diowave. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
