Events

Recall of Fabius GS Anesthesia Machine

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Draeger Medical, 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
    36476
  • Event Risk Class
    Class 2
  • Event Number
    Z-0048-2007
  • Event Initiated Date
    2006-10-03
  • Event Date Posted
    2006-10-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-08-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48711
  • 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
    Anesthesia Machine - Product Code BSZ
  • Reason
    One of four casters may break loose from chassis.
  • Action
    The recalling firm issued recall letters to their customers 10/03/2006 to inform them of the problem and that a service represenative will contact them to schedule an inspection of their machines. Should the inspections revealed any affected machines, the machines will be repaired free of charge.

Device

Fabius GS Anesthesia Machine
  • Model / Serial
    Catalog number 8604699
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and Canada.
  • Product Description
    Fabius GS Anesthesia Machine. Catalog number 8604699
  • Manufacturer
    Draeger Medical, Inc.

Manufacturer

Draeger Medical, Inc.
  • Manufacturer Address
    Draeger Medical, Inc., 3135 Quarry Rd, Telford PA 18969-1042
  • Manufacturer Parent Company (2017)
    Stefan Dräger GmbH
  • Source
    USFDA