Recall Z-1771-2013— Del Mar Reynolds Medical, Ltd.

Name: FDA recall Z-1771-2013
Creator: U.S. Food and Drug Administration
Published: 2013-06-07

Class II · Terminated

Class II FDA medical device recall by Del Mar Reynolds Medical, Ltd., initiated 2013-06-07, terminated 2013-08-29. It names one FDA 510(k) clearance: K113051. 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.. 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: Del Mar Reynolds Medical, Ltd.
Classification: Class II
Status: Terminated
Initiated: 2013-06-07
Terminated: 2013-08-29
Firm location: Hertford, N/A, United Kingdom

510(k) clearances named in this recall

1 on FDA's record

K113051 — SPACELABS ARKON ANESTHESIA WORKSTATIONSpacelabs Healthcare·cleared 2012-03-22

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.