BLEASE FRONTLINE PLUS RANGE, ANESTHESIA MACHINES - 440

• • Terminated Z-0352-2014 FDA Class I ·initiated 17 Oct 2013

  Spacelabs Healthcare Ltd. of United Kingdom recalls , and Service Kits, Part Number 050-0659-00 and 050-0901-00. The Bag to-Vent switch in CAS I/II Absorbers may fail due to loose fastening hardware in an absorber.

• • Terminated Z-0968-2013 FDA Class I ·initiated 15 Jan 2013 ·on shared 510(k) K003251

  A defect in CAS I/II Absorbers in the Spacelabs Anesthesia Workstations and Service Kits may cause a condition leading to an increase in the carbon dioxide concentration within the inspired gas being delivered to the patient.

• • Terminated Z-0565-2013 FDA Class II ·initiated 2 Nov 2012

  The BleaseFocus Anesthesia Workstation and 700/900 Series Ventilators were shipped with manuals that describe a secondary O2 Supply Failure alarm which has not been incorporated into the system. The manuals were prematurely updated for a feature that is not yet available.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K003251 ↗

FDA Product Code

BSZ

Models / Variants

440

560

690

FDA applicant

Blease Medical Equipment , Ltd.

Device Class

Class II

Regulation

21 CFR Part 868.5160

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Blease 6200 Anaesthesia Ventilator

  Class II

  FDA 510(k) K982132 Active Cleared 15 Apr 1999

• Modification to Blease Frontline Genius Range, Anesthesia Machines

  Class II

  FDA 510(k) K001727 Active Cleared 9 Aug 2000

• Blease Sirius Anesthesia System, Models 3000 and 2000

  Class II

  FDA 510(k) K041430 Active Cleared 7 Oct 2004

• Blease Frontline Genius Range Anaesthesia Machine

  Class II

  FDA 510(k) K982137 Active Cleared 9 Apr 1999