Events

Recall of Device Recall Sechrist Monoplace Hyperbaric Chamber with Electronic Control Module

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Sechrist Industries 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
    52796
  • Event Risk Class
    Class 2
  • Event Number
    Z-0209-2013
  • Event Initiated Date
    2008-08-28
  • Event Date Posted
    2012-11-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-11-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=84025
  • 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
    Chamber, hyperbaric - Product Code CBF
  • Reason
    Sechrist conducted a field upgrade on the hyperbaulic chambers equipped with electronic control modules in order to correct a software bug that could potentially affect the performance of the chamber.
  • Action
    Sechrist Industries contacted consignees by phone to notify them of a software upgarde and to schedule appointments to perform the required field upgrades. An approximate summary of the phone notification is provided below. "I am contacting you to notify you of a field upgrade we are performing on our hyperbaric chambers equipped with Electronic Control Modules in order to correct a software bug that could potentially affect the performance of your chamber. The upgrade includes the installation of a new motherboard with revised software, a reset switch, and the exchange of other control panel components. The process will take approximately 2.5 hours and will be performed at no charge to you." For questions regarding this recall call 714-579-8400.

Device

Device Recall Sechrist Monoplace Hyperbaric Chamber with Electronic Control Module
  • Model / Serial
    Serial Numbers: 360001-360049, 360051-360064, 360068.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of Bulgaria, and Canada
  • Product Description
    Sechrist Monoplace Hyperbaric Chamber with Electronic Control Module Model 3600E/ER || The Hyperbaric Chamber is intended to provide 100% oxygen to the patient at greater than ambient pressures
  • Manufacturer
    Sechrist Industries Inc

Manufacturer

Sechrist Industries Inc
  • Manufacturer Address
    Sechrist Industries Inc, 4225 E La Palma Ave, Anaheim CA 92807
  • Manufacturer Parent Company (2017)
    Sechrist Industries Inc.
  • Source
    USFDA