FDA-Device2022-08-24Class II
Power electronic box, Part #AS-0066, subassembly for the MyoCycle MC-2.
Myolyn Inc.
Hazard
Screws mounting an internal power supply may come loose during shipping resulting in increased risk of high voltage electrical shock.
Sold states
Distribution was made to AZ, CA, CT, FL, GA, ID, IL, KY, MA, MI, MN, MO, MN, NC, NJ, NM, NY, OH, OR, TX, UT, VA, WA, and WI. There was no foreign/military/government distribution.
Affected count
45 devices
Manufactured in
6931 Nw 22nd St Ste A, Gainesville, FL, United States
Products
Power electronic box, Part #AS-0066, subassembly for the MyoCycle MC-2.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1523-2022Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief