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Terminated

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

FDA Recall Z-2271-2015 · Posted 2015-07-27

Recalling FirmDraeger Medical, Inc.
Recall StatusTerminated
Product CodeBSZ
Date Initiated2015-06-22
Date Terminated2017-05-05
Product Quantity373

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.

Firm Action

Draeger Medical sent an Urgent Medical Device Recall Letter, dated June 2015, and Instructions for Use Supplement (one supplement for each Fabius MRI Anesthesia Machine at the facility) to end users. The letter identified the affected product, problem and actions to be taken. For questions regarding the recall letter contact Michael Kelhart at 1-800-543-5047 (press 1 at the prompt, then 2, then 32349). For questions regarding the operation and/or servicing of the Drger Fabius MRI anesthesia machine contact DrgerService Technical Support at 1-800-543-5047 (press 4 at the prompt).

Root Cause

Labeling False and Misleading

Distribution Pattern

US Nationwide Distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K072884FABIUS MRIDraeger Medical AG & Co. KG · 2008-07-30

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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