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U.S. Department of Health and Human Services

Class 2 Device Recall INTELECT MOBILE COMBO

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  Class 2 Device Recall INTELECT MOBILE COMBO see related information
Date Initiated by Firm December 17, 2007
Date Posted June 25, 2008
Recall Status1 Terminated 3 on February 19, 2010
Recall Number Z-1231-2008
Recall Event ID 46281
510(K)Number K031077  
Product Classification Muscle stimulator and therapeutic ultrasound - Product Code MPH
Product INTELECT MOBILE COMBO, Model No. 2778, Chattanooga Group, Hixson, TN 37343, Made in the USA, Not for sale in the U.S.A.
Code Information Serial numbers 1000 - 3541
Recalling Firm/
Manufacturer		 Chattanooga Corp Inc
4717 Adams Rd
Hixson TN 37343
For Additional Information Contact Mr. Ben Whalen
423-648-4945
Manufacturer Reason
for Recall		 Device malfunction: causing electric shock and burn.
FDA Determined
Cause 2		 Device Design
Action Beginning on 12/17/2007, Chattanooga Corp. sent two recall notification letters, via UPS mail, to its consignees informing them of the situation. The letters stated that the recall was to the user level and requested that the user perform the software upgrade, which will eliminate the possibility of shock and burn.
Quantity in Commerce 2541 units
Distribution Worldwide Distribution - including USA
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.
510(K) Database 510(K)s with Product Code = MPH and Original Applicant = CHATTANOOGA GROUP
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