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Myolyn Inc. Recall 90620

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

Myolyn Inc. Recall 90620 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1523-2022
Event ID90620
Event DescriptionPower electronic box, Part #AS-0066, subassembly for the MyoCycle MC-2.
Product TypeDevices
DistributionDistribution 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.
Quantity45 devices
Recall ReasonScrews mounting an internal power supply may come loose during shipping resulting in increased risk of high voltage electrical shock.
Device Classification20220824
Device Code InfoSerial 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
Center Classification Date20220816
Recall Initiation Date20220719
Recalling FirmMyolyn Inc.
Initial Notification Letter
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