Recall Z-1523-2022— Myolyn Inc.
Class II · Terminated
Class II FDA medical device recall by Myolyn Inc., initiated 2022-07-19, terminated 2024-09-23. It names one FDA 510(k) clearance: K213925. Product: Power electronic box, Part #AS-0066, subassembly for the MyoCycle MC-2.. Reason: Screws mounting an internal power supply may come loose during shipping resulting in increased risk of high voltage electrical shock..
- Recalling firm
- Myolyn Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2022-07-19
- Terminated
- 2024-09-23
- Firm location
- Gainesville, FL, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Power electronic box, Part #AS-0066, subassembly for the MyoCycle MC-2.
Reason for recall
Screws mounting an internal power supply may come loose during shipping resulting in increased risk of high voltage electrical shock.
Data sourced from openFDA. This site is unofficial and independent of the FDA.