Events

Recall of DatexOhmeda Aestiva/5

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
    28936
  • Event Risk Class
    Class 2
  • Event Number
    Z-0968-04
  • Event Initiated Date
    2004-04-16
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-11-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=32863
  • 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
    Apparatus, Gas-Scavenging - Product Code CBN
  • Reason
    Increased circuit pressure as a result of a misassembled aestiva/5 active gas scavenging system.
  • Action
    Recall letters, dated April 26, 2004, stated that a firm representative would contact the consignee to schedule a visit to verify the proper function of each device unit.

Device

DatexOhmeda Aestiva/5
  • Model / Serial
    Serial numbers AMVG01045, AMVG01047, AMVG01052, AMVG01062, AMVG01072 thru AMVG01083, AMVH00100 thru AMVH00109, AMVH00116, AMVH00125, AMVH00126, AMVH00129, AMVH00132, AMVH00133, AMVH00139, AMVH00141 thru AMVH00148, AMVH00151 thru AMVH00154, AMVH00159, AMVH00160, AMVH00164, AMVH00166, AMVH00159, AMVH00160, AMVH00164, AMVH00166, AMVH00171 thru AMVH00186, AMVH00195 thru AMVH00198, AMVH00211, and AMVH00228 thru AMVH00230
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The affected units were distributed nationwide in the United States and worldwide.
  • Product Description
    Datex-Ohmeda Aestiva/5 Active Gas Scavenging System, used with a Model 7100 Ventillator, on a Aestiva/5 Anesthesia Machine.
  • Manufacturer
    Datex-Ohmeda Inc

Manufacturer

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