Medical device recalls Moderate risk

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

Recall date
July 19, 2022
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1523-2022
FDA classification
Class II
Brand / firm
Myolyn Inc.
Sold / distributed
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.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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