iPico Product Usage: Muscle stimulation

FDA device recall Z-1140-2012 · posted 2012-03-01 · Terminated

Recall details

Recalling firm

Ion Genius, Inc.

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

Action taken

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.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

NFO

Quantity affected

72 cables in total, amounts of other devices not reported

Distribution

Worldwide Distribution - (USA) Nationwide Distribution

Date initiated

2012-01-06

Date posted

2012-03-01

Date terminated

2015-05-21

Location

Honolulu, HI