Recall Z-0072-2018— Spacelabs Healthcare, Ltd.

Name: FDA recall Z-0072-2018
Creator: U.S. Food and Drug Administration
Published: 2017-10-11

Class I · Terminated

Class I FDA medical device recall by Spacelabs Healthcare, Ltd., initiated 2017-10-11, terminated 2018-03-12. It names one FDA 510(k) clearance: K113051. Product: Arkon Anesthesia Delivery System, Model 99999, and software version 2.61 and upgrade kit 050-9043-00 Rev G. The Spacelabs Arkon Anesthesia Workstation is intended for use in the hospital environment and operating room. It 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. The device is intended for use only by a suitably qualified physician. Reason: Arkon Anesthesia Workstation, with software version 2.61, experienced failure in mechanical ventilation, oxygen and anesthetic gas delivery, with concurrent failure of the display unit that resulted in a blank screen without audible or visible alarms..

Recalling firm: Spacelabs Healthcare, Ltd.
Classification: Class I
Status: Terminated
Initiated: 2017-10-11
Terminated: 2018-03-12
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

Arkon Anesthesia Delivery System, Model 99999, and software version 2.61 and upgrade kit 050-9043-00 Rev G. The Spacelabs Arkon Anesthesia Workstation is intended for use in the hospital environment and operating room. It 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. The device is intended for use only by a suitably qualified physician

Reason for recall

Arkon Anesthesia Workstation, with software version 2.61, experienced failure in mechanical ventilation, oxygen and anesthetic gas delivery, with concurrent failure of the display unit that resulted in a blank screen without audible or visible alarms.

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