Draeger Medical, Inc. recalls Fabius MRI Anesthesia Machine; Fabius MRI is an inhalation anesthesia machine for use in MRI environments in operating,…

Recall date

June 22, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2271-2015

FDA classification

Class II

Brand / firm

Draeger Medical, Inc.

Sold / distributed

US Nationwide Distribution

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Fabius MRI Anesthesia Machine; Fabius MRI is an inhalation anesthesia machine for use in MRI environments in operating, induction and recovery rooms.