Draeger Fabius GS Premium, Fabius OS, Fabius Tiro, Fabius Tiro D-M Product Usage: used to administer anesthesia and vent

FDA device recall Z-0008-2014 · posted 2013-10-10 · Terminated

Recall details

Recalling firm

Draeger Medical, Inc.

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.

Action taken

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

Status

Terminated

Product code

BSZ

Quantity affected

1127 units

Distribution

Worldwide distribution: US (nationwide) and countries of: Argentina, Australia, Austria, Azerbaijan, Bangladesh, Brazil, Bulgaria, Canada, Chile, China, Columbia, Ecuador, Egypt, France, Germany, Gree

Date initiated

2013-08-14

Date posted

2013-10-10

Date terminated

2014-09-23

Location

Telford, PA

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