Recall Z-2589-2018— Spacelabs Healthcare, Ltd.

Name: FDA recall Z-2589-2018
Creator: U.S. Food and Drug Administration
Published: 2018-07-11

Class I · Terminated

Class I FDA medical device recall by Spacelabs Healthcare, Ltd., initiated 2018-07-11, terminated 2024-03-20. It names one FDA 510(k) clearance: K113051. Product: Arkon Anesthesia Delivery System with Arkon Software Version 2.70, Display Unit Assembly 650-1769-00 installed, and Model #: 99999. This system includes a ventilator. 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 Delivery System may go into a failed state (mechanical ventilation ceases) while the machine is in use or while idle..

Recalling firm: Spacelabs Healthcare, Ltd.
Classification: Class I
Status: Terminated
Initiated: 2018-07-11
Terminated: 2024-03-20
Firm location: Hertford, 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 with Arkon Software Version 2.70, Display Unit Assembly 650-1769-00 installed, and Model #: 99999. This system includes a ventilator. 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 Delivery System may go into a failed state (mechanical ventilation ceases) while the machine is in use or while idle.

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