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.
Spacelabs is recalling anesthesia workstations with software version 2.61 because they can fail to deliver oxygen and anesthetic gases while showing a blank screen with no alarms. This could lead to serious patient risks during surgery.
The software version 2.61 causes mechanical ventilation, oxygen delivery, and anesthetic gas systems to fail simultaneously. The display shows a blank screen with no audible or visible alarms, so medical staff cannot detect the problem.
Healthcare providers using Spacelabs Arkon anesthesia workstations with software version 2.61 in hospitals or operating rooms are affected. Patients undergoing anesthesia are at risk if the workstation fails during surgery.
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.
Verify the software version on the device; if it's 2.61, it's affected.
Reach out to Spacelabs Healthcare for repair or software update options.
No, the device is intended for hospital and operating room use only.
Check for model number 99999 and software version 2.61, or upgrade kit 050-9043-00 Rev G.
Contact Spacelabs Healthcare for repair or software update options.
We’ve drafted a message you can send Spacelabs to request your refund or repair — edit it as you like.
Subject: Recall Z-0072-2018 — Spacelabs Spacelabs Hello, I own a Spacelabs that is covered by recall Z-0072-2018 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.
