Events

Recall of Device Recall Hidrex USA DP450

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

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
    76362
  • Event Risk Class
    Class 3
  • Event Number
    Z-1236-2017
  • Event Initiated Date
    2017-01-30
  • Event Date Posted
    2017-02-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-08-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152974
  • 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
    Device, iontophoresis, other uses - Product Code EGJ
  • Reason
    The device was reclassified from a class iii device to a class ii device and there are new documentation requirements.
  • Action
    Distributor sent recall notification letter to affected dealers and end users on 2/10/17. Notification letter will include a copy of the addendum to the user manual. The device is not instructed to be returned.

Device

Device Recall Hidrex USA DP450
  • Model / Serial
    SN# 16-3.7091 to 16-3.7134, 17-3.7001 to 17-3.7020
  • Product Classification
    Physical Medicine Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide throughout the US
  • Product Description
    Hidrex USA DP450
  • Manufacturer
    Hidrex GmbH

Manufacturer

Hidrex GmbH
  • Manufacturer Address
    Hidrex GmbH, Otto-Hahn-Str. 12, Heiligenhaus Germany
  • Manufacturer Parent Company (2017)
    Hidrex Gmbh
  • Source
    USFDA