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.
FDA Recall Z-2589-2018 · Posted 2018-08-10
Recalling FirmSpacelabs Healthcare, Ltd.
Recall StatusTerminated
Product CodeCBK
Date Initiated2018-07-11
Date Terminated2024-03-20
Product Quantity328
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.
Firm Action
The firm, Spacelabs Healthcare, sent "Field Corrective Action Display Unit Resets" letters dated 7/3/2018 and 7/9/2018 to its customers via priority service on 07/11/2018. The letters informed them to circulate this notification to all affected persons and to add copies to appropriate user manuals. The firm will contact customers to replace the display assembly..
Customers with questions are encouraged to call Technical Support at 1-425-363-5212.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Worldwide Distribution: U.S (nationwide) to states of.: LA, NE, CO, WY, MT, NM, IN, ME, NY, IL, MA, TX, PA, PR; and countries (OUS) of: PERU BOLIVIA, PANAMA, MALAYSIA, POLAND, IRELAND, MOROCCO, MEXICO, CANADA, UNITED KINGDOM, FRANCE, and CHINA, ECUADOR.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.