FDAClass IIAugust 24, 2022

Power electronic box recall

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

Why was Power electronic box recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Power electronic box, Part #AS-0066, subassembly for the MyoCycle MC-2.
Recalling firm
Myolyn Inc.
Quantity
45 devices
Distribution
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.
Recall date
August 24, 2022
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls