Events

Recall of Device Recall HealthPax Cranial Electrotherapy Stimulator

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Health Directions, Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    38459
  • Event Risk Class
    Class 3
  • Event Number
    Z-1242-2007
  • Event Initiated Date
    2007-07-19
  • Event Date Posted
    2007-09-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-06-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=53805
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Cranial Electrotherapy Stimulator - Product Code JXK
  • Reason
    Peak voltage test result not in acceptable limits.
  • 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.

Device

Device Recall HealthPax Cranial Electrotherapy Stimulator
  • Model / Serial
    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 Classification
    Neurological Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide, including USA, Canada, Ireland, and India.
  • Product Description
    HealthPax Cranial Electrotherapy Stimulator
  • Manufacturer
    Health Directions, Inc

Manufacturer

Health Directions, Inc
  • Manufacturer Address
    Health Directions, Inc, 1609 Woodbourne Rd Ste 203b, Levittown PA 19057-1538
  • Source
    USFDA