Events

Recall of Device Recall Fabius MRI 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
    71592
  • Event Risk Class
    Class 2
  • Event Number
    Z-2271-2015
  • Event Initiated Date
    2015-06-22
  • Event Date Posted
    2015-07-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-05-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138314
  • 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
    The fabius mri or parts of the system were attracted by the magnetic field of the mri. if the fabius mri is positioned too close to the mri, its parts can be loosened as a result of the magnetic force of the mri.
  • Action
    Draeger Medical sent an Urgent Medical Device Recall Letter, dated June 2015, and Instructions for Use Supplement (one supplement for each Fabius MRI Anesthesia Machine at the facility) to end users. The letter identified the affected product, problem and actions to be taken. For questions regarding the recall letter contact Michael Kelhart at 1-800-543-5047 (press 1 at the prompt, then 2, then 32349). For questions regarding the operation and/or servicing of the Dr¿ger Fabius MRI anesthesia machine contact Dr¿gerService Technical Support at 1-800-543-5047 (press 4 at the prompt).

Device

Device Recall Fabius MRI Anesthesia Machine
  • Model / Serial
    Catalog Number(s): 8607300
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution
  • Product Description
    Fabius MRI Anesthesia Machine; Fabius MRI is an inhalation anesthesia machine for use in MRI environments in operating, induction and recovery rooms.
  • 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