FDA Medical Device Recalls (openFDA)
Myolyn Inc.: Power electronic box, Part #AS-0066, subassembly for the MyoCycle MC-2.
- Recall number
- Z-1523-2022
- Recalling firm
- Myolyn Inc.
- Product
- Power electronic box, Part #AS-0066, subassembly for the MyoCycle MC-2.
- Status
- Terminated
- Initiated
- 2022-07-19
- Posted
- not on file
- Terminated
- 2024-09-23
- Reason
- Screws mounting an internal power supply may come loose during shipping resulting in increased risk of high voltage electrical shock.
- Root cause
- 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
- 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.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K213925"]
- PMA numbers
- not on file
- Product code
- GZI
- Firm FEI
- 3013503259
- Firm city
- Gainesville
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28