Z-1242-2007

HealthPax Cranial Electrotherapy Stimulator

Name: Z-1242-2007 HealthPax Cranial Electrotherapy Stimulator
Creator: Health Directions, Inc
Published: 2007-07-19
License: https://open.fda.gov/license/

Health Directions, Inc / initiated 2007-07-19 / Terminated

FDA source

Health Directions, Inc began a recall of HealthPax Cranial Electrotherapy Stimulator on 2007-07-19. The reason FDA records is "Peak voltage test result not in acceptable limits". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1242-2007
Status: Terminated
Initiated: 2007-07-19
Posted: 2007-09-26
Terminated: 2008-06-03
Recalling firm: Health Directions, Inc
Product: HealthPax Cranial Electrotherapy Stimulator
Product code: JXK Cranial Electrotherapy Stimulator To Treat Depression
Reason for recall: Peak voltage test result not in acceptable limits.
FDA root cause: 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.
Product codes and lots: 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.

Product code JXK

K883812Class IIHp-1 (Healthpax)Healthdirections, Inc. / cleared 1988-11-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)