CLASS I Device recall · Reported 29 Nov 2017 · FDA Enforcement Report

Arkon Anesthesia Delivery System recalled by Spacelabs Healthcare

Spacelabs Healthcare is recalling Arkon Anesthesia Delivery System, distributed nationwide in the US. The recall was initiated on 11 Oct 2017 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesUDI: 10841522100017

Quantity recalled110 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0072-2018
FDA event ID: 78330
Recalling firm: Spacelabs Healthcare, Hertford, N/A
Classification: Class I
Status: Terminated
Recall initiated: 11 Oct 2017
FDA classified: 21 Nov 2017
Reported: 29 Nov 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: CPAP & Ventilators

Timeline

11 Oct 2017	Recall initiated by company
21 Nov 2017	Classified by FDA	+41 days
29 Nov 2017	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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

Where it was distributed

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

Nationwide Alabama Colorado Connecticut Florida Maine Mississippi North Carolina New Mexico Wyoming

Questions about this recall

Why was it recalled?

Which lots are affected?

UDI: 10841522100017

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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