Z-1523-2022 Class II Terminated

Recalled by Myolyn Inc. — Gainesville, FL

Recall Details

Product Type
Devices
Report Date
August 24, 2022
Initiation Date
July 19, 2022
Termination Date
September 23, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
45 devices

Product Description

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 Pattern

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.

Code Information

Serial numbers 000800 thru 000819, 000821 thru 000822, 000824 thru 000827, 000829 thru 000831, 000835, 000836, 000840 thru 000842, 000850 thru 000852, and 000857 thru 000859; UDI 000861553000417