FDA recall Z-0072-2018

Product

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

Nationwide Distribution to the states of NM, WY, FL, NC, MS, CO, CT, ME, and AL.

Key facts

Status

Terminated

Initiation date

2017-10-11

Report date

2017-11-29

Termination date

2018-03-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

Hertford, N/A, United Kingdom

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0072-2018