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U.S. Department of Health and Human Services

Class 1 Device Recall Fabius Tiro M

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  Class 1 Device Recall Fabius Tiro M see related information
Date Initiated by Firm March 01, 2018
Date Posted May 08, 2018
Recall Status1 Terminated 3 on April 16, 2019
Recall Number Z-1484-2018
Recall Event ID 79773
510(K)Number K042419  
Product Classification Gas-machine, anesthesia - Product Code BSZ
Product Fabius Tiro M, anesthesia machine, catalog no. 8608400

Product Usage:
The products are inhalation anesthesia machines for use in operating, induction and recovery rooms. They may be used with O2, N2O, and AIR supplied by a medical gas pipeline system or by externally mounted gas cylinders. Fabius series anesthesia machines are equipped with an electrically driven and electronically controlled ventilator and monitors for airway pressure (P), volume (V), and inspiratory oxygen concentration (FiO2).
Code Information Serial no. ASKK-0001
Recalling Firm/
Manufacturer		 Draeger Medical, Inc.
3135 Quarry Rd
Telford PA 18969-1042
Manufacturer Reason
for Recall		 The automatic ventilation may fail if the position detection of the motor is disturbed. If the ventilator cover is damaged, manual ventilation may also fail.
FDA Determined
Cause 2		 Process control
Action On March 1, 2018, the recalling firm notified affected customers via an Urgent Medical Device Recall letter. The recalling firm stated that customers would receive replacement motors for potentially affected devices. Until the replacement occurred, customers were instructed to continue to operate their devices with the usual attention and make sure that a manual resuscitator for emergency ventilation is kept ready according to the instructions for use. Customers were also supplied with a reply card to indicate that they had received the notification. Customers with questions about the letter were directed to call Michael Kelhart between 8AM-4:30PM EST at 1-800-437-2437 (press 1 at the prompt, then 32349). Questions regarding the operation and/or servicing of the Draeger Fabius anesthesia machine were directed to DraegerService Technical Support between the hours of 8:00 AM  8:00 PM EST at 1-800-437-2437 (press 4 at the prompt then 4 again).
Quantity in Commerce 1
Distribution US Nationwide Distribution to accounts in 21 states: AZ, CA, CO, ID, IL, KS, MA, MI, MS, NC, NY, OH, OK, PA, RI, TN, TX, UT, VA, WA, WI; and PR.
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, INC.
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