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U.S. Department of Health and Human Services

Class 2 Device Recall Perfector

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  Class 2 Device Recall Perfector see related information
Date Initiated by Firm January 06, 2012
Date Posted March 01, 2012
Recall Status1 Terminated 3 on May 21, 2015
Recall Number Z-1137-2012
Recall Event ID 61073
Product Classification Stimulator, muscle, powered - Product Code IPF
Product Perfector

Product Usage: Muscle stimulation
Code Information All leads
Recalling Firm/
Manufacturer		 Ion Genius, Inc.
7192 Kalanianaole Hwy Ste D-204A
Honolulu HI 96825-1800
For Additional Information Contact Xanya Sofra-Weiss, PhD.
808-395-0656
Manufacturer 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
FDA Determined
Cause 2		 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 in Commerce 72 cables in total, amounts of other devices not reported
Distribution Worldwide Distribution - (USA) Nationwide Distribution
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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