FDA Recall: Defect in Air-In-Line Software Algorithm

Company: Zyno Medical LLC
Date of Enforcement Report: 10/9/2024
Class II

PRODUCT

Z-800 Infusion System, Model Numbers Z-800, Z-800F, Z-800W, Z-800WF; Software Version: Z-800 6.1.01 and 6-1.07z; Z-800F 4.1.02 and 4.1.08z; Z-800W 3.1.32 and 3.1.64z, Z-800WF 3.1.32 and 3.1.64z

Recall Number:

Z-0005-2025

REASON:

There is a defect in the air-in-line software algorithm.

RECALLING FIRM/MANUFACTURER:

Zyno Medical LLC

VOLUME OF PRODUCT IN COMMERCE:

1819 units

DISTRIBUTION:

US Nationwide

About the author

Allison joined SoftwareCPR in 2022, bringing along over ten years of passion for building teamwork and growth in organizations. This is established in part by the greatest University the South has to offer- Mississippi State.

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