Avea

• 12 recalls, same reason

  • Terminated Z-1894-2016 FDA Class I ·initiated 17 May 2016
  • Terminated Z-1888-2016 FDA Class I ·initiated 17 May 2016
  • Terminated Z-1892-2016 FDA Class I ·initiated 17 May 2016
  • Terminated Z-1897-2016 FDA Class I ·initiated 17 May 2016
  • Terminated Z-1895-2016 FDA Class I ·initiated 17 May 2016
  • Terminated Z-1896-2016 FDA Class I ·initiated 17 May 2016
  • Terminated Z-1898-2016 FDA Class I ·initiated 17 May 2016
  • Terminated Z-1899-2016 FDA Class I ·initiated 17 May 2016
  • Terminated Z-1889-2016 FDA Class I ·initiated 17 May 2016
  • Terminated Z-1890-2016 FDA Class I ·initiated 17 May 2016
  • Terminated Z-1893-2016 FDA Class I ·initiated 17 May 2016
  • Terminated Z-1891-2016 FDA Class I ·initiated 17 May 2016

  CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect F1 fuse on the AVEA Ventilator Transducer Communication Alarm (TCA) Board which may fail/blow, causing loss of power to the User Interface Module (UIM).

• • Terminated Z-2273-2013 FDA Class I ·initiated 5 Sep 2013

  CareFusion has identified a potential risk associated with AVEA ventilators when used at higher altitudes. A proactive complaint review identified an error in the barometric pressure compensation. CareFusion is voluntarily initiating a field correction of the affected devices to correct the error.

• • Terminated Z-0510-2012 FDA Unclassified (pre-2012) ·initiated 8 Sep 2011

  The recall was initiated because Carefusion has identified a potential risk associated with certain AVEA ventilators and affected replacement parts manufactured between March 1, 2009 and June 30, 2011. Carefusion is voluntarily initiating a field correction of the affected devices to preclude the possibility of this risk.

• 5 recalls, same reason

  • Terminated Z-0985-2008 FDA Unclassified (pre-2012) ·initiated 17 Dec 2007
  • Terminated Z-0986-2008 FDA Unclassified (pre-2012) ·initiated 17 Dec 2007
  • Terminated Z-0984-2008 FDA Unclassified (pre-2012) ·initiated 17 Dec 2007
  • Terminated Z-0982-2008 FDA Unclassified (pre-2012) ·initiated 17 Dec 2007
  • Terminated Z-0983-2008 FDA Unclassified (pre-2012) ·initiated 17 Dec 2007

  Alarm Failure -- There is a potential of alarms not being activated subsequent to specific electronic faults that may cause INOP condition.

510(k) Number

K013642 ↗

FDA Product Code

CBK

Device Class

Class II

Regulation

21 CFR Part 868.5895

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Bird 1000 Pv Portable Ventilator

  Class II

  FDA 510(k) K925422 Active Cleared 13 May 1993

• Bird Avea Ventilator

  Class II

  FDA 510(k) K022674 Active Cleared 6 Nov 2002

• 6400ST Interface MODULE-RS232

  Class II

  FDA 510(k) K880721 Active Cleared 14 Apr 1988

• Bird Avian Port Military Vent Nsn 6530-01-374-8903

  Class II

  FDA 510(k) K933262 Active Cleared 29 Jul 1993

• Bird Microblender M.R.I.

  Class II

  FDA 510(k) K895695 Active Cleared 6 Jul 1990

• Bird 6500 Air Compressor

  Class II

  FDA 510(k) K864547 Active Cleared 12 Jan 1987

See all devices from Bird Products Corp. →