Recall – Anesthesia Delivery System; Class I

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

PRODUCT
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:

REASON
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..

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

VOLUME OF PRODUCT IN COMMERCE
253 units in the U.S.

DISTRIBUTION
U.S.

62304 Software Training Course – February 23-25, 2021

IEC 62304 and Emerging Standards and FDA Expectations for Medical Device and Health IT Software – Virtual

This very popular 3-day course provides a clear understanding of applying IEC 62304 standard for medical device software and much more. The course compares and contrasts 62304 with FDA expectations and discusses approaches for alignment. In addition, participants will learn of other relevant standards and technical reports pertinent to medical device software, HealthIT, medical mobile apps, and Software as a Medical Device (SaMD) products (e.g., 82304, 80002-1, 14971, 80001-2-x, 62366).

Participants will gain practical advice and pragmatic experience with all types of medical software. Participants will leave with a clear understanding of how to effectively and efficiently integrate 62304 compliance into their software development lifecycle (SDLC).

Register (click):  EventZilla Registration Site

Need info?  Email us at training@softwarecpr.com

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.