Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall MyoCycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall MyoCycle see related information
Date Initiated by Firm July 19, 2022
Create Date August 16, 2022
Recall Status1 Open3, Classified
Recall Number Z-1523-2022
Recall Event ID 90620
510(K)Number K213925  
Product Classification Stimulator, neuromuscular, external functional - Product Code GZI
Product Power 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 Contact Alan 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
Action The 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 Commerce 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.
Total Product Life Cycle TPLC 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = GZI and Original Applicant = Myolyn, LLC
-
-