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
Enforcement
- Recall Number
- Z-0072-2018
- Event ID
- 78330
- Classification
- Class I
- Status
- Terminated
- Product Type
- Devices
- Firm
- Spacelabs Healthcare, Ltd.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 29, 2017
- Initiation Date
- October 11, 2017
- Classification Date
- November 21, 2017
- Termination Date
- March 12, 2018
- Address
- Foxholes Centre, Unit B, John Tate Road, Hertford, N/A, N/A, United Kingdom
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
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.
UDI: 10841522100017
Nationwide Distribution to the states of NM, WY, FL, NC, MS, CO, CT, ME, and AL.
110 units