Summary
The FDA issued a Class II for Power electronic box, Part #AS-0066, subassembly for the MyoCycle MC-2. by Myolyn Inc.. Reason: Screws mounting an internal power supply may come loose during shipping resulting in increased risk of high voltage electrical shock..
Details
Source
Device Recall
External ID
Z-1523-2022
Action Date
2022-08-24
Status
Terminated
Category
device
Product Description
Power electronic box, Part #AS-0066, subassembly for the MyoCycle MC-2.
Lot/Code Info: 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
Quantity Affected: 45 devices
Reason for Recall
Screws mounting an internal power supply may come loose during shipping resulting in increased risk of high voltage electrical shock.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-07-19
Company
Gainesville, FL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 132 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Myolyn Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Myolyn Inc. have FDA actions?
This is the only FDA action we have on record for Myolyn Inc. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1523-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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