Z-1139-2012

Iellios

Name: Z-1139-2012 Iellios
Creator: Ion Genius, Inc.
Published: 2012-01-06
License: https://open.fda.gov/license/

Ion Genius, Inc. / initiated 2012-01-06 / Terminated / root cause: manufacturing process

FDA source

Ion Genius, Inc. began a recall of IELLIOS Product Usage: Muscle stimulation on 2012-01-06. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1139-2012
Status: Terminated
Initiated: 2012-01-06
Posted: 2012-03-01
Terminated: 2015-05-21
Recalling firm: Ion Genius, Inc.
Product: IELLIOS Product Usage: Muscle stimulation
Product code: NFO Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Reason for recall: 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 tag: manufacturing process
FDA 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 808-222-2664 or email [email protected].
Quantity in commerce: 72 cables in total, amounts of other devices not reported
Distribution: Worldwide Distribution - (USA) Nationwide Distribution
Product codes and lots: all units

Product code NFO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)