Spacelabs Arkon Anesthesia Workstation

• • Terminated Z-2589-2018 FDA Class I ·initiated 11 Jul 2018

  Arkon Anesthesia Delivery System may go into a failed state (mechanical ventilation ceases) while the machine is in use or while idle.

• • Terminated Z-0072-2018 FDA Class I ·initiated 11 Oct 2017 ·on shared 510(k) K113051

  Arkon Anesthesia Workstation, with software version 2.61, experienced failure in mechanical ventilation, oxygen and anesthetic gas delivery, with concurrent failure of the display unit that resulted in a blank screen without audible or visible alarms.

• • Terminated Z-2093-2017 FDA Class II ·initiated 14 Apr 2017 ·on shared 510(k) K113051

  Reports of the Canister Carrier breaking during absorbent exchange or during anesthesia machine transit, causing a leak in the breathing circuit, which could cause hypoventilation in the patient.

• • Terminated Z-1460-2017 FDA Class II ·initiated 8 Feb 2017

  Spacelabs has received reports of the Arkon Anesthesia Delivery System, Model 99999, shutting down without warning. The power supply has failed in a way that does not trigger the normal on battery alarms.

• • Terminated Z-1442-2014 FDA Class I ·initiated 10 Mar 2014

  The System may go into a controlled failed state if a series of parameters on the user interface are activated in a specific sequence.

• • Terminated Z-1771-2013 FDA Class II ·initiated 7 Jun 2013

  Spacelabs ARKON Anesthesia System is recalled due to software defect. The System Status Computer may incorrectly determine that a communication error has occurred. If this situation occurs, a buzzer will activate and a yellow triangle will be displayed on the System Status Computer screen that alerts the user of this error.

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

510(k) Number

K113051 ↗

FDA Product Code

CBK

Device Class

Class II

Regulation

21 CFR Part 868.5895

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

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See all devices from Spacelabs Healthcare Inc. →