Fabius Gs/Fabius Tiro Anesthesia System

• 2 recalls, same reason

  • Terminated Z-2250-2018 FDA Class II ·initiated 24 May 2018
  • Terminated Z-2251-2018 FDA Class II ·initiated 24 May 2018

  The Draeger anesthesia device may be able to dose 100% N2O. In the event of a fault, the S-ORC module would not prevent setting an N2O flow that would result in a hypoxic mixture from being dosed to the patient. Potential adverse outcomes include death of the patient.

• 3 recalls, same reason

  • Terminated Z-1484-2018 FDA Class I ·initiated 1 Mar 2018
  • Terminated Z-1482-2018 FDA Class I ·initiated 1 Mar 2018
  • Terminated Z-1483-2018 FDA Class I ·initiated 1 Mar 2018

  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.

• • Terminated Z-0008-2014 FDA Class I ·initiated 14 Aug 2013

  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.

• 2 recalls, same reason

  • Terminated Z-2478-2010 FDA Unclassified (pre-2012) ·initiated 26 Aug 2010
  • Terminated Z-2479-2010 FDA Unclassified (pre-2012) ·initiated 26 Aug 2010

  potential failures to Electri-Cord Manufacturing AC power cord

• • Terminated Z-2338-2008 FDA Unclassified (pre-2012) ·initiated 7 Jul 2008

  The parent company became aware of instances where the lower side rail of the frame of the machine broke inwards when being moved across a threshold; resulting in the machine being unstable.

• • Terminated Z-1315-2008 FDA Unclassified (pre-2012) ·initiated 5 Feb 2008

  Detachment of Component: The chassis on some machines were manufactured out of specifications. As a result, the caster may break loose from the chassis.

• • Terminated Z-0048-2007 FDA Unclassified (pre-2012) ·initiated 3 Oct 2006

  One of four casters may break loose from chassis

510(k) Number

K042419 ↗

FDA Product Code

BSZ

Device Class

Class II

Regulation

21 CFR Part 868.5160

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

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• Evite Xl

  Class II

  FDA 510(k) K083050 Active Cleared 29 Dec 2008

• Vapor 19

  Class II

  FDA 510(k) K771899 Active Cleared 18 Oct 1977

• Nbp Cuff

  Class II

  FDA 510(k) K092999 Active Cleared 24 Nov 2009

• Narkomed 6000 Model Number NM6000

  Class II

  FDA 510(k) K980553 Active Cleared 4 Aug 1998

See all devices from Draeger Medical, Inc. →