FDA Medical Device Recalls (openFDA)
Health Directions, Inc: HealthPax Cranial Electrotherapy Stimulator
- Recall number
- Z-1242-2007
- Recalling firm
- Health Directions, Inc
- Product
- HealthPax Cranial Electrotherapy Stimulator
- Status
- Terminated
- Initiated
- 2007-07-19
- Posted
- 2007-09-26
- Terminated
- 2008-06-03
- Reason
- Peak voltage test result not in acceptable limits.
- 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
- 212 units
- Distribution
- Worldwide, including USA, Canada, Ireland, and India.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K883812"]
- PMA numbers
- not on file
- Product code
- JXK
- Firm FEI
- 2529026
- Firm city
- Levittown
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28