Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Spacelabs ARKON Anesthesia Workstation. Spacelabs ARKON Anesthesia Workstation may be Recalled by Del Mar Reynolds Medical, Ltd. Due to Spacelabs ARKON Anesthesia System is recalled due to...

Date: June 7, 2013
Company: Del Mar Reynolds Medical, Ltd.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Del Mar Reynolds Medical, Ltd. directly.

Affected Products

Spacelabs ARKON Anesthesia Workstation. Spacelabs ARKON Anesthesia Workstation may be used for the delivery of oxygen, air and nitrous oxide in a controlled manner to various patient breathing circuits with or without the use of mechanical ventilator, and may be used for the delivery of anesthetic vapor by use of a dismountable vaporizer.

Quantity: 9 units (4 in the US and 5 outside US)

Why Was This Recalled?

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.

Where Was This Sold?

Worldwide Distribution - USA including South Carolina and internationally to Canada and Great Britian.

About Del Mar Reynolds Medical, Ltd.

Del Mar Reynolds Medical, Ltd. has 8 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report