Events

Recall of DatexOhmeda S/5 Aespire Anesthesia System 7100

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
    33678
  • Event Risk Class
    Class 2
  • Event Number
    Z-0039-06
  • Event Date Posted
    2005-10-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-04-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=42273
  • 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
    Two conditions may occur with the s/5 aespire anesthesia system. the internal auxiliary flowmeter tubing may become disconnected if the auxiliary oxygen supply tubing is occluded and the patient may not receive desired supplemental oxygen which could lead to serious injury if undetected. also the o2 switch may leak or fail.
  • Action
    Urgent Medical Device Correction letter dated 09/23/05 was sent to all customers. The letter describes the issues, affected device serial numbers and recommends that customers DO NOT USE the internal auxiliary oxygen flowmeter, if installed in their system, and to use alternate auxiliary oxygen sources, i.e. wall-mounted oxygen flow meter, in the interim. A GE service representative will contact the customers to schedule an upgrade, performed at no charge.

Device

DatexOhmeda S/5 Aespire Anesthesia System 7100
  • Model / Serial
    AMZJ00111 thru AMZJ00146
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    CA, CO, FL, GA, IL, IN, MI, MS, NM, OK, PA, PR, SD, UT & WA. OUS to: Algeria, Argentina, Australia, Austria, Bahrain, Belgium, Canada, Caribbean, Czech Republic, Chile, China, Colombia, Dominican Republic, Ecuador, Finland, France, Germany, Ghana, Great Britain, Hong Kong, India, Indonesia, Israel, Italy, Japan, Korea, Kuwait, Latvia, Lebanon, Lithuania, Malaysia, Mexico, Oman, Palestine, Peru, Poland, Portugal, Saudi Arabia, Slovenia, South Africa, Spain, Switzerland, United Arab Emerites, Venezuela & Vietnam.
  • Product Description
    Datex-Ohmeda Aespire Carestation. This device is not marketed in the US.
  • Manufacturer
    Datex-Ohmeda Inc

Manufacturer

Datex-Ohmeda Inc
  • Manufacturer Address
    Datex-Ohmeda Inc, 3030 Ohmeda Drive, PO Box 7550, zip 53707-7550, Madison WI 53718
  • Source
    USFDA