Events

Recall of HealthPax (HP1). Cranial Electrotherapy Stimulator GZJ

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
    28852
  • Event Risk Class
    Class 2
  • Event Number
    Z-0019-05
  • Event Initiated Date
    2004-04-08
  • Event Date Posted
    2004-10-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-10-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=35278
  • 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
    Stimulator, Cranial Electrotherapy - Product Code JXK
  • Reason
    Implied claims (extremes of compulsive or addictive behavior) are outside the scope of clearance for the device.
  • 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.

Device

HealthPax (HP1). Cranial Electrotherapy Stimulator GZJ
  • Model / Serial
    HealthPax (HP-1)
  • Product Classification
    Neurological Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    The product was shipped to wholesalers and retailers in CA, MA, NJ, NY, PA, TX, and WA.
  • Product Description
    HealthPax (HP-1). Cranial Electrotherapy Stimulator
  • Manufacturer
    Health Directions, Inc

Manufacturer

Health Directions, Inc
  • Manufacturer Address
    Health Directions, Inc, 81 Big Oak Rd, Morrisville PA 19067-7801
  • Source
    USFDA