Use cautionMedical device recall · FDA · Published October 11, 2017
Spacelabs Arkon Anesthesia Workstation Software 2.61: Risk of Ventilation Failure
Spacelabs recalls Arkon anesthesia workstations with software version 2.61 due to potential mechanical ventilation failure and blank display without alarms. Affected units may need repair or software update.
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.
Take action
Contact the company
📍Recalling firmSpacelabs Healthcare, Ltd.Foxholes Centre, Unit B, John Tate Road · Hertford, United Kingdom
“Spacelabs Arkon Anesthesia Workstation Software 2.61: Risk of Ventilation Failure.” GovInfoNow, updated September 14, 2026. https://govinfonow.com/recall/72867-spacelabs-arkon-anesthesia-workstation-software-2-61-risk-of-ventilation. Based on FDA recall #Z-0072-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0072-2018%22&limit=1).
The FDA announced on Oct. 11, 2017, that Spacelabs Healthcare is recalling the Arkon Anesthesia Delivery System due to potential mechanical ventilation and gas delivery failures. The agency said the device may also display a blank screen without alarms.
How to tell if you have it
Brand: Spacelabs
Product: Arkon Anesthesia Delivery System
Model: 99999
Software version: 2.61
Upgrade kit: 050-9043-00 Rev G
Units affected: 110
The hazard
According to the FDA, the Arkon Anesthesia Workstation with software version 2.61 experienced failure in mechanical ventilation, oxygen and anesthetic gas delivery. This was accompanied by a concurrent failure of the display unit resulting in a blank screen without audible or visible alarms.
Context
GovInfoNow's records show Spacelabs Healthcare has 4 other recalls on record since July 11, 2018. Other recent recalls of similar products include Draeger Atlan A350XL Anesthesia Workstation Recall (May 7, 2026), Draeger Atlan A350 Anesthesia Workstation Recall (May 7, 2026), and Datex-Ohmeda Et Control Software Option for Anesthesia Gas Machines Recall (July 30, 2026).
How to tell if you have this one
Check for the model number 99999 and software version 2.61 on the device. The recall includes units sold with upgrade kit 050-9043-00 Rev G.
Brand
Spacelabs
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Software Version
Verify the software version on the device; if it's 2.61, it's affected.
Contact Spacelabs
Reach out to Spacelabs Healthcare for repair or software update options.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 9 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Nationwide Distribution to the states of NM, WY, FL, NC, MS, CO, CT, ME, and AL.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Colorado, Connecticut, Florida, Maine, Mississippi, New Mexico, North Carolina, Wyoming.
Recall timeline
FDA terminated this recall 5 months after the firm started it.
1Firm started the recall
2FDA classified it Class I
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0072-2018 (October 11, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0072-2018 to see it in context.
Plain-language summary written by qwen3:4b on September 14, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.