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U.S. Department of Health and Human Services

Class 2 Device Recall Fabius MRI Anesthesia Machine

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  Class 2 Device Recall Fabius MRI Anesthesia Machine see related information
Date Initiated by Firm June 22, 2015
Date Posted July 27, 2015
Recall Status1 Terminated 3 on May 05, 2017
Recall Number Z-2271-2015
Recall Event ID 71592
510(K)Number K072884  
Product Classification Gas-machine, anesthesia - Product Code BSZ
Product Fabius MRI Anesthesia Machine; Fabius MRI is an inhalation anesthesia machine for use in MRI environments in operating, induction and recovery rooms.
Code Information Catalog Number(s): 8607300
Recalling Firm/
Manufacturer		 Draeger Medical, Inc.
3135 Quarry Rd
Telford PA 18969-1042
For Additional Information Contact Customer Support
215-721-5400
Manufacturer 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.
FDA Determined
Cause 2		 Labeling False and Misleading
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 Dr¿ger Fabius MRI anesthesia machine contact Dr¿gerService Technical Support at 1-800-543-5047 (press 4 at the prompt).
Quantity in Commerce 373
Distribution US Nationwide Distribution
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = BSZ and Original Applicant = DRAEGER MEDICAL AG & CO. KG
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