Class 2 Device Recall INTELECT ADVANCED

• Date Initiated by Firm: December 17, 2007
• Date Posted: June 25, 2008
• Recall Status: Terminated on February 19, 2010
• Recall Number: Z-1225-2008
• Recall Event ID: 46281
• 510(K)Number: K031077
• Product Classification: Muscle stimulator and therapeutic ultrasound - Product Code MPH
• Product: INTELECT ADVANCED, Model No. 2752CC, Chattanooga Group, Hixson, TN 37343, Made in the USA, Not for sale in the U.S.A.
• Code Information: Serial numbers 1000 - 1079
• 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: 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: 79 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