Events

Recall of Device Recall DatexOhmeda

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Datex-Ohmeda 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
    28182
  • Event Risk Class
    Class 2
  • Event Number
    Z-0545-04
  • Event Initiated Date
    2004-02-03
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-11-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=31339
  • 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
    Gas-Machine, Anesthesia - Product Code BSZ
  • Reason
    Anesthetic agents could be delivered at concentrations above the concentration set on the s/5 and as/3 anesthesia delivery units (adu) having serial numbers within a specified range.
  • Action
    Recall letters dated February 03, 2004 stated that a firm representative would contact the consignee to schedule a visit to replace software and hardware to correct the problem.

Device

Device Recall DatexOhmeda
  • Model / Serial
    The affected units in the United States have serial numbers between 40013635 and 40162379.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The product was distributed nationwide to hospitals in the Unites States.
  • Product Description
    Datex-Ohmeda S/5 and AS/3 Anesthesia Delivery Units || (The S/5 units are a later version of the AS/3 units. The conversion from AS3 to S5 occurred during the summer of 2000. This change was mainly a product name change, with a slight color variation to the shade of white being used externally on the machine. There were no design or feature and function modifications when the name change occurred.)
  • Manufacturer
    Datex-Ohmeda Inc

Manufacturer

Datex-Ohmeda Inc
  • Manufacturer Address
    Datex-Ohmeda Inc, One Ohmeda Dr. Box 7550, Madison WI 53707
  • Source
    USFDA