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
Check against the official notice below — it lists the full affected range.
Spacelabs Healthcare, Ltd. has recalled 110 units of the Arkon Anesthesia Workstation, Model 99999, with software version 2.61 and upgrade kit 050-9043-00 Rev G. The devices experienced simultaneous failures in mechanical ventilation, oxygen delivery, and anesthetic gas delivery, while the display unit failed with a blank screen. During these failures, neither audible nor visible alarms functioned to alert operators to the problem.
The affected units were distributed nationwide to facilities in New Mexico, Wyoming, Florida, North Carolina, Mississippi, Colorado, Connecticut, Maine, and Alabama. The recalled devices can be identified by UDI 10841522100017. The recall notice does not specify what actions affected consumers should take in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. Quantity: 110 units Lot/code info: UDI: 10841522100017
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.