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Recall Observatory FDA recall evidence

Device product

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

Z-2271-2015

June 22, 2015

Class II

Product summary

Firm
Draeger Medical, Inc.
Event
Event 71592
Status
Terminated
Classification
Class II
Quantity
373
Official record key
device-enforcement:Z-2271-2015

Official wording

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.

Code information: Catalog Number(s): 8607300

Distribution pattern: US Nationwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.