Spacelabs Arkon Anesthesia System with Software 2.70 May Fail During Use
Spacelabs Healthcare recalls Arkon Anesthesia Delivery Systems with specific software and display units that may stop working mid-use, risking patient safety. Affected units have unique serial numbers listed in the recall notice.
Use caution until it’s fixed
Arkon Anesthesia Delivery System may go into a failed state (mechanical ventilation ceases) while the machine is in use or while idle.
Contact the company
What happened, in plain English
Spacelabs Healthcare is recalling anesthesia delivery systems with software version 2.70 and display unit assembly 650-1769-00 that may stop working during use or when idle. This could lead to mechanical ventilation failure, putting patients at risk. Read more at govinfonow.com/recall/70637-spacelabs-arkon-anesthesia-system-with-software-2-70-may-fail.
Source Summary by GovInfoNow · govinfonow.com/recall/70637-spacelabs-arkon-anesthesia-system-with-software-2-70-may-fail · Updated August 20, 2026 · FDA enforcement record: FDA #Z-2589-2018
Cite this page
“Spacelabs Arkon Anesthesia System with Software 2.70 May Fail During Use.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/70637-spacelabs-arkon-anesthesia-system-with-software-2-70-may-fail. Based on FDA recall #Z-2589-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2589-2018%22&limit=1).
Why it’s dangerous
The system may unexpectedly stop functioning (mechanical ventilation ceases) while in use or when idle. This could interrupt oxygen delivery to patients, potentially causing harm during anesthesia procedures.
Who’s affected
Healthcare providers using the Arkon Anesthesia Workstation in hospitals or operating rooms are most at risk. Patients receiving anesthesia through this system could be affected if the device fails.
How to tell if you have this one
Check for the specific software version (2.70) and display unit assembly (650-1769-00). Affected units have unique serial numbers listed in the recall notice, including many starting with ARKN- or arkn-.
- Brand
Spacelabs- Category
Medical device
What to do — step by step
Check Device Serial Number
Look for the serial number on the device, which may start with ARKN- or arkn- as listed in the recall notice.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 13 states.
FDA distribution: “Worldwide Distribution: U.S (nationwide) to states of.: LA, NE, CO, WY, MT, NM, IN, ME, NY, IL, MA, TX, PA, PR; and countries (OUS) of: PERU BOLIVIA, PANAMA, MALAYSIA, POLAND, IRELAND, MOROCCO, MEXICO, CANADA, UNITED KINGDOM, FRANCE, and…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Colorado, Illinois, Indiana, Louisiana, Maine, Massachusetts, Montana, Nebraska, New Mexico, New York, Pennsylvania, Puerto Rico, Texas, Wyoming.
Recall timeline
FDA terminated this recall 5.7 years after the firm started it.
- Firm started the recall
- FDA classified it Class I
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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-2589-2018 (July 11, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2589-2018 to see it in context.
- Plain-language summary written by qwen3:4b on August 20, 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.