HAMILTON T1 Ventilator REF 161006 1610060 161009 1610090 Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates
Reported: August 2, 2023 Initiated: June 15, 2023 #Z-2140-2023
Product Description
HAMILTON T1 Ventilator REF 161006 1610060 161009 1610090 Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates
Reason for Recall
Due to a software anomaly after approximately 91 days of cumulative use, the ventilator may stop and enter the ambient mode without prior notice.
Details
- Recalling Firm
- Hamilton Medical, Inc.
- Units Affected
- 2319 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
- Location
- Reno, NV
Frequently Asked Questions
What product was recalled? ▼
HAMILTON T1 Ventilator REF 161006 1610060 161009 1610090 Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates. Recalled by Hamilton Medical, Inc.. Units affected: 2319 systems.
Why was this product recalled? ▼
Due to a software anomaly after approximately 91 days of cumulative use, the ventilator may stop and enter the ambient mode without prior notice.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 2, 2023. Severity: Critical. Recall number: Z-2140-2023.
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