Zyno Medical recalls Z-800F Infusion Systems with unverified software versions installed. Affected units may have security risks from unvalidated software updates.
Unreleased software versions were installed on distributed devices without verification or validation.
Zyno Medical is recalling Z-800F Infusion Systems that were installed with unverified software versions. This could lead to security risks if the software isn't properly validated before use.
The recall states that unverified software versions were installed on distributed devices without proper validation or verification. This means the software might not be safe for medical use, potentially leading to security risks or incorrect treatment outcomes.
Healthcare professionals using the Z-800F Infusion System for intravenous treatments are likely affected. Patients receiving blood or fluid infusions through this system may be at risk if the software is unverified.
Check for the model number Z800F on the device. The serial numbers listed in the recall include a range from 600091 to 608612. The product was distributed with unverified software versions.
Look for the serial number on the device to see if it matches the list of affected numbers provided in the recall.
The recall states that unverified software versions were installed on distributed devices without proper validation or verification.
The official notice does not specify a remedy, so check the device serial number against the list provided to determine if it is affected.
The recall does not mention specific patient risks, but unverified software could potentially lead to security issues or incorrect treatment outcomes.
We’ve drafted a message you can send Zyno Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1866-2025 — Zyno Medical Zyno Medical Hello, I own a Zyno Medical that is covered by recall Z-1866-2025 from Zyno Medical. 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.
