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U.S. Department of Health and Human Services

Class 2 Device Recall Fabius MRI

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  Class 2 Device Recall Fabius MRI see related information
Date Initiated by Firm December 16, 2021
Create Date January 14, 2022
Recall Status1 Terminated 3 on April 17, 2023
Recall Number Z-0501-2022
Recall Event ID 89243
510(K)Number K072884  
Product Classification Gas-machine, anesthesia - Product Code BSZ
Product Draeger Fabius MRI Anesthesia Machine, Catalog Number 8607300
Code Information UDI 04048675041498 Serial Numbers ASPJ-0019 ASPJ-0020 ASPJ-0021 ASPK-0001 ASPK-0002
Recalling Firm/
Manufacturer		 Draeger Medical, Inc.
3135 Quarry Rd
Telford PA 18969-1042
For Additional Information Contact Michael A. Kelhart
215-660-2349
Manufacturer Reason
for Recall		 26 Fabius MRI Anesthesia machines were distributed with internal hoses routing Oxygen to the Oxygen Flush and Oxygen Flow Control interchanged. If the hospital O2 Central supply pressure is not stable, the O2 fresh gas flow could deviate from the adjusted value. If the deviation is not noticed, insufficient oxygenation of the patient may occur.
FDA Determined
Cause 2		 Process control
Action On December 17, 2021, the firm notified customers via Urgent Medical Device Correction Notice. Customers were instructed to do the following: Please ensure that all users of the above-mentioned products and other concerned persons within your organization are made aware of this Urgent Medical Device Correction Notice. If you have provided the products to third parties, please forward a copy of this information. Please keep this information at least until the corrective measure has been completed. Please also complete and return the attached Customer Acknowledgment Card to confirm to us that you have received this information. A Dr¿ger Service representative will contact you to arrange a date for the correction to be performed free of charge. Until the repair has been concluded you may continue using the device under constant supervision as long as appropriate O2-monitoring is in place and a suitable alarm limit is set. Please consider a suitable buffer when adjusting the O2 flow. If you have any questions regarding the operation of your Fabius MRI Anesthesia Machine, please contact Dr¿ger Service Technical Support between the hours of 8:00 AM 8:00 PM EST at 1-800-437- 2437 (press 2 at the prompt, then 2, then 2 again). If you have any questions regarding this recall communication, please contact Michael Kelhart between the hours of 8:00 AM 4:30 PM EST at 1-800-437-2437 (press 1 at the prompt, then 32349).
Quantity in Commerce 5
Distribution US Nationwide distribution in the states of NY, PA, and WI.
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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