Recall Z-1139-2012 ยท NFO Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Ion Genius, Inc.
IELLIOS Product Usage: Muscle stimulation
| Date | Mar 1, 2012 (initiated Jan 6, 2012) |
| Status | Terminated |
| Reason | Wires do not meet performance standards under 21 CFR 898 and have unprotected electrode configurations. Additionally, devices were sold/distributed without 510(k) or PMA |
| Root cause | Nonconforming Material/Component |
| Action | Ion Genius sent a Medical Device Product Recall letters to all affected customers on January 6, 2012. The letter identified the affected products, problem and actions to be taken. The letter instructed customers to check their inventory for the affected products and return immediately to Ion Genius for replacements. Customers returning affected products should call the firm so that a shipping label can be provided. Customers were instructed to be completed the Response Form and returned to Ion Genius by fax at 808-395-0787. For questions and concerns contact Xanya Sofra-Weiss at 808-222-266 |
| Quantity | 72 cables in total, amounts of other devices not reported |
| Distribution | Worldwide Distribution - (USA) Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.