Spacelabs Healthcare, Ltd.: Medical Device Recall in 2017 - (Recall #: Z-0072-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

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

Product Classification:

Class I

Date Initiated: October 11, 2017

Date Posted: November 29, 2017

Recall Number: Z-0072-2018

Event ID: 78330

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.

Status: Terminated

Product Quantity: 110 units

Code Information:

UDI: 10841522100017

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated