FDA Medical Device Recalls (openFDA)
Ion Genius, Inc.: IELLIOS Product Usage: Muscle stimulation
- Recall number
- Z-1139-2012
- Recalling firm
- Ion Genius, Inc.
- Product
- IELLIOS Product Usage: Muscle stimulation
- Status
- Terminated
- Initiated
- 2012-01-06
- Posted
- 2012-03-01
- Terminated
- 2015-05-21
- 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 808-222-2664 or email x@arasysperfector.com.
- Quantity
- 72 cables in total, amounts of other devices not reported
- Distribution
- Worldwide Distribution - (USA) Nationwide Distribution
- Lot, serial or model codes
- all units
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- NFO
- Firm FEI
- 3003588228
- Firm city
- Honolulu
- Firm state
- HI
- 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