Device product
Power electronic box, Part #AS-0066, subassembly for the MyoCycle MC-2.
Z-1523-2022
Product summary
- Firm
- Myolyn Inc.
- Event
- Event 90620
- Status
- Terminated
- Classification
- Class II
- Quantity
- 45 devices
- Official record key
device-enforcement:Z-1523-2022
Official wording
Reason: Screws mounting an internal power supply may come loose during shipping resulting in increased risk of high voltage electrical shock.
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
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.
Derived failure modes
-
Unknown
Screws mounting an internal power supply may come loose during shipping resulting in increased risk of high voltage electrical shock.