Recall Z-2271-2015— Draeger Medical, Inc.

Name: FDA recall Z-2271-2015
Creator: U.S. Food and Drug Administration
Published: 2015-06-22

Class II · Terminated

Class II FDA medical device recall by Draeger Medical, Inc., initiated 2015-06-22, terminated 2017-05-05. It names one FDA 510(k) clearance: K072884. Product: Fabius MRI Anesthesia Machine; Fabius MRI is an inhalation anesthesia machine for use in MRI environments in operating, induction and recovery rooms.. 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..

Recalling firm: Draeger Medical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-06-22
Terminated: 2017-05-05
Firm location: Telford, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K072884 — FABIUS MRIDraeger Medical AG & Co. KG·cleared 2008-07-30

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.