Recall Z-0008-2014— Draeger Medical, Inc.

Name: FDA recall Z-0008-2014
Creator: U.S. Food and Drug Administration
Published: 2013-08-14

Class I · Terminated

Class I FDA medical device recall by Draeger Medical, Inc., initiated 2013-08-14, terminated 2014-09-23. It names one FDA 510(k) clearance: K042419. Product: 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.. Reason: 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..

Recalling firm: Draeger Medical, Inc.
Classification: Class I
Status: Terminated
Initiated: 2013-08-14
Terminated: 2014-09-23
Firm location: Telford, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K042419 — FABIUS GS/FABIUS TIRO ANESTHESIA SYSTEMDraeger Medical, Inc.·cleared 2004-10-08

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.