Z-0072-2018 Class I Terminated
Recall Details
- Product Type
- Devices
- Report Date
- November 29, 2017
- Initiation Date
- October 11, 2017
- Termination Date
- March 12, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 110 units
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.
Distribution Pattern
Nationwide Distribution to the states of NM, WY, FL, NC, MS, CO, CT, ME, and AL.
Code Information
UDI: 10841522100017