Recall Z-1523-2022 ยท GZI Stimulator, Neuromuscular, External Functional
Myolyn Inc.
Power electronic box, Part #AS-0066, subassembly for the MyoCycle MC-2.
| Date | Jul 19, 2022 |
| Status | Terminated |
| 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 |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K213925 | MyoCycle MC-2 (Home / Home + / Pro / Pro +) Myolyn, LLC, Apr 25, 2022 |