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U.S. Department of Health and Human Services

Class 2 Device Recall HealthPax (HP1). Cranial Electrotherapy Stimulator GZJ

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  Class 2 Device Recall HealthPax (HP1). Cranial Electrotherapy Stimulator GZJ see related information
Date Initiated by Firm April 08, 2004
Date Posted October 14, 2004
Recall Status1 Terminated 3 on October 14, 2004
Recall Number Z-0019-05
Recall Event ID 28852
Product Classification Cranial Electrotherapy Stimulator To Treat Depression - Product Code JXK
Product HealthPax (HP-1). Cranial Electrotherapy Stimulator
Code Information HealthPax (HP-1)
Recalling Firm/
Manufacturer		 Health Directions, Inc
81 Big Oak Rd
Morrisville PA 19067-7801
For Additional Information Contact Harold Stecker, Ph.D.
215-269-0400
Manufacturer Reason
for Recall		 Implied claims (extremes of compulsive or addictive behavior) are outside the scope of clearance for the device
FDA Determined
Cause 2		 Other
Action The recalling firm issued a letter to their customers dated 4/8/04 informing them of the problem. The letter explained that the manual was changed due to unacceptable text. The consignees were instructed to change the user manuals prior to shipping.
Quantity in Commerce 3475 units
Distribution The product was shipped to wholesalers and retailers in CA, MA, NJ, NY, PA, TX, and WA.
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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