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U.S. Department of Health and Human Services

Class 3 Device Recall HealthPax Cranial Electrotherapy Stimulator

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  Class 3 Device Recall HealthPax Cranial Electrotherapy Stimulator see related information
Date Initiated by Firm July 19, 2007
Date Posted September 26, 2007
Recall Status1 Terminated 3 on June 03, 2008
Recall Number Z-1242-2007
Recall Event ID 38459
510(K)Number K883812  
Product Classification Cranial Electrotherapy Stimulator - Product Code JXK
Product HealthPax Cranial Electrotherapy Stimulator
Code Information All units puchased after December 21, 2006. Serial numbers: 7001, 7003, 7004, 7005, 7006, 7008, 7009, 7010, 7013, 7014, 7015, 7016, 7017, 7018, 7019, 7020, 7021, 7022, 7023, 7024, 7025, 7026, 7027, 7028, 7029, 7030, 7031, 7032, 7033, 7034, 7036, 7037, 7038, 7039, 7040, 7041, 7042, 7043, 7044, 7045, 7046, 7047, 7048, 7049, 7050, 7051, 7052, 7053, 7054, 7055, 7056, 7057, 7058, 7059, 7060, 7061, 7062, 7063, 7064, 7065, 7066, 7067, 7068, 7069, 7070, 7071, 7072, 7073, 7074, 7075, 7076, 7077, 7078, 7079, 7080, 7081, 7082, 7083, 7084, 7085, 7086, 7087, 7088, 7089, 7090, 7092, 7093, 7094, 7095, 7096, 7097, 7098, 7099, 7100, 7101, 7102, 7103, 7104, 7105, 7106, 7107, 7108, 7109, 7110, 7111, 7112, 7113, 7114, 7115, 7116, 7117, 7118, 7119, 7120, 7121, 7122, 7123, 7124, 7125, 7126, 7127, 7128, 7129, 7130, 7131, 7132, 7133, 7134, 7135, 7136, 7137, 7138, 7139, 7140, 7141, 7142, 7146, 7147, 7148, 7151, 7152, 7153, 7154, 7155, 7156, 7157, 7158, 7159, 7160, 7161, 7162, 7163, 7164, 7165, 7166, 7167, 7168, 7169, 7170, 7171, 7172, 7173, 7174, 7175, 7176, 7177, 7178, 7179, 7180, 7181, 7182, 7183, 7184, 7185, 7186, 7187, 7188, 7189, 7190, 7191, 7192, 7193, 7194, 7195, 7196, 7197, 7198, 7199, 7202, 7203, 7204, 7205, 7206, 7210, 7211, 7213, 7214, 7232, 7233, 7250, 7251, 7253, 7254, 7255, 7269, 7282, 7284, 7285, 7286, and 7329.
Recalling Firm/
Manufacturer		 Health Directions, Inc
1609 Woodbourne Rd Ste 203b
Levittown PA 19057-1538
For Additional Information Contact Harold Stecker, Ph.D.
215-269-0400
Manufacturer Reason
for Recall		 Peak voltage test result not in acceptable limits.
FDA Determined
Cause 2		 Other
Action The recalling firm sent a recall letter 07/30/2007 to all their customers. The letter indicated that it is necessary to return the product for testing and the device will either be returned or if necessary replaced. Each unit will be tested with an oscilloscope device to determine whether it meets or fails design specifications. The recalling firm will reimburse shipping costs.
Quantity in Commerce 212 units
Distribution Worldwide, including USA, Canada, Ireland, and India.
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.
510(K) Database 510(K)s with Product Code = JXK and Original Applicant = HEALTHDIRECTIONS, INC.
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