RegWardenFDA facility compliance records
Recall

Class II — Draeger Medical, Inc.

Recalling firmDraeger Medical Systems, Inc.
Registered facilityView this company's 2 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass II
StatusTerminated
Reasonthe 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.
ProductFabius MRI Anesthesia Machine; Fabius MRI is an inhalation anesthesia machine for use in MRI environments in operating, induction and recovery rooms.
Quantity373
DistributionUS Nationwide Distribution
Initiated2015-06-22
Classified2015-07-27
Terminated2017-05-05
Recall numberZ-2271-2015
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — Draeger Medical, Inc. (Z-2271-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/71592/

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