21

Jul

2023

FDA Recall: Software Anomaly- After 91 days use, Ventilator May Stop Without Warning

0

Company: Hamilton Medical, Inc.
Date of Enforcement Report: 07/21/2023
Class I

PRODUCT

HAMILTON C1 Ventilator REF 161001 1610010 Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates.

Recall Number:

Z-2139-2023

REASON:

Due to a software anomaly after approximately 91 days of cumulative use, the ventilator may stop and enter the ambient mode without prior notice.

RECALLING FIRM/MANUFACTURER:

Hamilton Medical, Inc.

VOLUME OF PRODUCT IN COMMERCE:

689 systems

DISTRIBUTION:

U.S.: Alabama Alaska Arizona Arkansas California Colorado Connecticut Delaware Florida Georgia Hawaii Idaho Illinois Indiana Iowa Kansas Kentucky Louisiana Maine Maryland Massachusetts Michigan Minnesota Mississippi Missouri Montana Nebraska Nevada New Hampshire New Jersey New York North Carolina North Dakota Ohio Oklahoma Oregon Pennsylvania Rhode Island South Carolina South Dakota Tennessee Texas Utah Vermont Virginia Washington West Virginia Wisconsin Wyoming Added 08/30/2023 – Puerto Rico O.U.S.: Bahamas, Japan and Mexico

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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