Device product
Mito Red Light, Super Mobile
Z-2478-2026
Product summary
- Event
- Event 98999
- Status
- Ongoing
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
device-enforcement:Z-2478-2026
Official wording
Reason: The near-infrared therapy device contains a lithium-ion battery that may malfunction, causing it to catch fire or burst into flames.
Code information: All Serial/Lot numbers/No UDI
Distribution pattern: Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NL, NM, NV, NY, OH, OR, PA, PR, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV and the countries of Australia, Canada, China, Japan, New Zealand, Spain, Switzerland, United Arab Emirates, United Kingdom.
Derived failure modes
-
Unknown
The near-infrared therapy device contains a lithium-ion battery that may malfunction, causing it to catch fire or burst into flames.