Vero Biotech recalls GENOSYL DS nitric oxide delivery system with serial numbers listed; reports of insufficient nitric oxide delivery during console transitions after software update 2.2.3.
Reports received of NO measured below desired dose during transition between primary console and backup console since Software Version 2.2.3 was uploaded to consoles in the field.
Vero Biotech is recalling their GENOSYL DS nitric oxide delivery system because reports indicate it may not deliver the proper dose of nitric oxide when switching between primary and backup consoles after a specific software update. This could affect medical treatment effectiveness.
The system may not deliver the correct nitric oxide dose when switching between the primary and backup consoles after software version 2.2.3 was updated. This could lead to improper medical treatment.
Patients using the GENOSYL DS system for medical nitric oxide delivery are affected. Those with the specific serial numbers listed in the recall are most at risk.
Check if your GENOSYL DS system has a serial number listed in the provided list (e.g., G0803, G0807, etc.). The product was sold with software version 2.2.3 or later.
Verify your GENOSYL DS system's serial number against the list provided in the recall.
Reports received indicate the GENOSYL DS may not deliver the proper nitric oxide dose during transitions between primary and backup consoles after software version 2.2.3 was uploaded.
Check your serial number against the list provided in the recall. If it matches, contact Vero Biotech for further instructions.
The recall mentions software version 2.2.3 was uploaded to consoles in the field, but no specific fix is stated in the recall.
We’ve drafted a message you can send Vero Biotech to request your refund or repair — edit it as you like.
Subject: Recall Z-1863-2021 — Vero Biotech Vero Biotech Hello, I own a Vero Biotech that is covered by recall Z-1863-2021 from Vero Biotech. 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.
