PlainRecalls
FDA Devices Critical Class I Terminated

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 anest

Reported: August 22, 2018 Initiated: July 11, 2018 #Z-2589-2018

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.

Details

Units Affected
328
Distribution
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.
Location
Hertford

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by Spacelabs Healthcare, Ltd.. Units affected: 328.
Why was this product recalled? ▼
Arkon Anesthesia Delivery System may go into a failed state (mechanical ventilation ceases) while the machine is in use or while idle.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 22, 2018. Severity: Critical. Recall number: Z-2589-2018.

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