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Terminated

Draeger Fabius GS Premium, Fabius OS, Fabius Tiro, Fabius Tiro D-M Product Usage: used to administer anesthesia and ventilation to patients during surgical procedures.

FDA Recall Z-0008-2014 · Posted 2013-10-10

Recalling FirmDraeger Medical, Inc.
Recall StatusTerminated
Product CodeBSZ
Date Initiated2013-08-14
Date Terminated2014-09-23
Product Quantity1127 units

Reason for Recall

During final testing of the Draeger Fabius GS Premium, Fabius OS, and Fabius Tiro anesthesia machines, some units did not pass the high voltage test and the minimum clearance between an electrical component and the unit housing was not maintained for some from a specific batch.

Firm Action

The firm, Drager, sent an "Urgent Medical Device Recall" letter dated August 2013 to its customers. The letter described the product, problem and actions to be taken. The letter informed the customers that in the event of a failure, manual ventilation mode should be used and that Draeger reps would be contacting customers to schedule the replacement of the power supply. The customers were instructed to notify personnel accordingly. If you have any questions, contact Director, Quality at 1-800-543-5047 (press 1 at the prompt, then 2, then 32349). For questions regarding the operation and/or servicing of your Draeger anesthesia machine please contact DragerService Technical Support at 1-800-543-5047 (press 4 at the prompt).

Root Cause

Device Design

Distribution Pattern

Worldwide distribution: US (nationwide) and countries of: Argentina, Australia, Austria, Azerbaijan, Bangladesh, Brazil, Bulgaria, Canada, Chile, China, Columbia, Ecuador, Egypt, France, Germany, Greece, Hungary, India, Indonesia, Israel, Italy, Ivory Coast, Japan, Kazakhstan, Latvia, Libya, Lithuania Malaysia, Morocco, Myanmar, Nepal, Philippines, Poland, Rumania, Russian Fed., Saudi Arabia, Senegal, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, Uruguay, Vietnam, White Russia Turkmenistan.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K042419FABIUS GS/FABIUS TIRO ANESTHESIA SYSTEMDraeger Medical, Inc. · 2004-10-08

Official Source

View FDA Recall →

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

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