FDA recall Z-1523-2022

Product

Power electronic box, Part #AS-0066, subassembly for the MyoCycle MC-2.

Reason for recall

Screws mounting an internal power supply may come loose during shipping resulting in increased risk of high voltage electrical shock.

Distribution

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.

Key facts

Status

Terminated

Initiation date

2022-07-19

Report date

2022-08-24

Termination date

2024-09-23

Voluntary/Mandated

Voluntary: Firm initiated

Location

Gainesville, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1523-2022