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U.S. Department of Health and Human Services

Class 2 Device Recall MyoCycle

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 Class 2 Device Recall MyoCyclesee related information
Date Initiated by FirmJuly 19, 2022
Create DateAugust 16, 2022
Recall Status1 Terminated 3 on September 23, 2024
Recall NumberZ-1523-2022
Recall Event ID 90620
510(K)NumberK213925 
Product Classification Stimulator, neuromuscular, external functional - Product Code GZI
ProductPower electronic box, Part #AS-0066, subassembly for the MyoCycle MC-2.
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
Recalling Firm/
Manufacturer		 Myolyn Inc.
6931 Nw 22nd St Ste A
Gainesville FL 32653-1231
For Additional Information ContactAlan Hamlet, Ph. D.
847-847-8856
Manufacturer Reason
for Recall		Screws mounting an internal power supply may come loose during shipping resulting in increased risk of high voltage electrical shock.
FDA Determined
Cause 2		Device Design
ActionThe recalling firm issued letters dated 7/19/2022 via email on 7/19/2022 informing the consignee of the reason for recall, risk to health, and action to be taken by the customer/user. The letter informs the addressee that the firm will ship a replacement power electronics box to all customers affected by the recall and the customers are asked to replace their original power electronics box with the new box and then return the original box to the recalling firm. The letter explains that instructions for replacing the box and a return UPS shipping label are enclosed with the replacement power electronics box. For customers who are unable or unwilling to replace their original power electronics box, a MYOLYN representative will travel to the customer location to perform the replacement. For customers who have received a device that has exhibited any signs of failure, they were instructed to discontinue use and disconnect it from the main electronical supply. If no power failures have been observed, customers can continue to use their device but should be cautious when transporting it to prevent the power supply mounting screws from loosening. The customer is to acknowledge receipt and understanding of the letter by clicking on the link in the letter or scanning the QR code to open the Recall Acknowledgement Form.
Quantity in Commerce45 devices
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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = GZI
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