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.
Arkon Anesthesia Delivery System may go into a failed state (mechanical ventilation ceases) while the machine is in use or while idle.
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.
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.
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.
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-.
Look for the serial number on the device, which may start with ARKN- or arkn- as listed in the recall notice.
The recalled device is the Spacelabs Arkon Anesthesia Delivery System with software version 2.70 and display unit assembly 650-1769-00.
Check the serial number on your device; affected units have unique serial numbers listed in the recall notice, including many starting with ARKN- or arkn-.
The recall notice does not specify a remedy, so contact Spacelabs Healthcare directly for guidance.
We’ve drafted a message you can send Spacelabs to request your refund or repair — edit it as you like.
Subject: Recall Z-2589-2018 — Spacelabs Spacelabs Hello, I own a Spacelabs that is covered by recall Z-2589-2018 from Spacelabs. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
