Events

Recall of FABIUS MRI

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by DRAEGERWERK AG & CO. KGAA.

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
    146111
  • Event Risk Class
    II
  • Event Initiated Date
    2015-06-10
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Draeger has become aware of cases in which 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 the magnetic force of the mri can loosen parts of the fabius mri and cause personal injury.

Device

FABIUS MRI
  • Model / Serial
    Model Catalog: 8607300 (Lot serial: ASHA-0001); Model Catalog: 8607300 (Lot serial: ASAF-0001); Model Catalog: 8607300 (Lot serial: ASDD-0111); Model Catalog: 8607300 (Lot serial: ASFM-0169); Model Catalog: 8607300 (Lot serial: ASCK-0034); Model Catalog: 8607300 (Lot serial: ASAD-0005); Model Catalog: 8607300 (Lot serial: ASFK-0134); Model Catalog: 8607300 (Lot serial: ASCJ-0260); Model Catalog: 8607300 (Lot serial: ASCC-0113); Model Catalog: 8607300 (Lot serial: ASCC-0112); Model Catalog: 8607300 (Lot serial: ARZD-0008); Model Catalog: 8607300 (Lot serial: ARZD-0007); Model Catalog: 8607300 (Lot serial: ARZB-0004); Model Catalog: 8607300 (Lot serial: ASEB-0154); Model Catalog: 8607300 (Lot serial: ASDD-0060); Model Catalog: 8607300 (Lot serial: ASFC-0050); Model Catalog: 8607300 (Lot serial: ASCM-0295); Model Catalog: 8607300 (Lot serial: ASAF-0002); Model Catalog: 8607300 (Lot serial: ASFD-0196)
  • Product Description
    FABIUS MRI
  • Manufacturer
    DRAEGERWERK AG & CO. KGAA

Manufacturer

DRAEGERWERK AG & CO. KGAA