Company: Del Mar Reynolds Medical, Ltd.
Date of Enforcement Report: 7/31/2013
Class lI:

PRODUCT

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. Recall Number Z-1771-2013

REASON
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.

RECALLING FIRM/MANUFACTURER
Del Mar Reynolds Medical, Ltd., Hertford, GB on 6/7/2013. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
9 units (4 in the US and 5 outside US)

DISTRIBUTION
Nationally and Internationally

___________________________________