Recall – Anesthesia Delivery System; Class I

Company: Spacelabs Healthcare, Ltd
Date of Enforcement Report 8/10/2018
Class I:

The Arkon Anesthesia Delivery System is intended for use in hospitals and operating rooms. It may be used to deliver oxygen, air, and nitrous oxide in a controlled manner to various patient breathing circuits (accessory sets that include tubing and breathing bags) with or without the use of a mechanical ventilator, and may be used for the delivery of anesthetic vapor (anesthesia that can be inhaled) with a dismountable vaporizer.

Recall Number:

Spacelabs Healthcare recalled the Arkon Anesthesia Delivery System due to the system going into a “failed state,” during which the mechanical ventilation function stops working, while the machine is in use, or while idle. The firm has not identified the reason for the failed state. When the machine goes into a failed state, a buzzer sounds, and the following image is shown on the large display monitor: Warning image, which consists of a yellow triangle with black exclamation point, and images of hands using manual ventilation, and a hand selecting emergency oxygen. Caption: Failed state warning image, which alerts users of the error, and indicates that manual ventilation and emergency oxygen are available alternatives. During the failed state, the anesthesiologist cannot access mechanical ventilation or monitor ventilation, which could increase the risk of patient injury. Emergency oxygen, vaporized agent delivery, and manual ventilation are still available. The firm has not received any reports of malfunctions, injuries, or deaths. Continued use of this product may cause serious adverse health consequences, including death..

Spacelabs Healthcare, Ltd/. Snoqualmie, WA 98065 on 7/11/2018. Voluntary: Firm Initiated recall is ongoing.

253 units in the U.S.


CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email for more info.

Corporate Office

15148 Springview St
Tampa, FL 33624
Partners located in the US (CA, FL, MA, MN) and Italy.