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Recall Observatory FDA recall evidence

Device product

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

Z-1523-2022

July 19, 2022

Class II

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

    reason.no_named_rule · v1.0.0

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