Nov

2024

FDA Recall: WiFi Software Not Compatible with Pump Software

Company: Zyno Medical LLC
Date of Enforcement Report: 11/22/2024

Class: III

PRODUCT

Brand Name: Z-800 Infusion System Product Name: Z-800WF Model/Catalog Number: Z-800WF. The Z-800 Infusion system is intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient under the direction or supervision physician or other certified healthcare professional.

Recall Number:

Z-0523-2025

REASON:

For the Z-800WF pumps, the WiFi software was not compatible with the pump software that had been loaded in accordance with ongoing correction Z-1183-2024.

RECALLING FIRM/MANUFACTURER:

Zyno Medical LLC.

VOLUME OF PRODUCT IN COMMERCE:

100 units

DISTRIBUTION:

Domestic: AL, FL, LA, MI, NE, NJ, OH, TX.

About the author

Allison Pate

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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FDA Recall: WiFi Software Not Compatible with Pump Software

Allison Pate

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