FDA recall Z-2020-2024

Product

Ventilator HAMILTON-C6, PN: 160021

Reason for recall

Ventilator may enter sensor fail mode, ventilation may not re-initiate, after patient is reconnected, which may cause hypoxia, if this sequence occurs: 1)User presses O2 enrichment, 2)User disconnects endotracheal tube for open suctioning, 3)Sensor error initiated, sensor fail mode occurs, 4)Patient is re-connected with sensor fail mode active, 5) Ventilation is not re-initiated by the ventilator.

Distribution

US Nationwide distribution in the states of GA, KY, FL, IN, NV, MI, VA, OR, TX, SC, CA, PA.

Key facts

Status

Ongoing

Initiation date

2024-05-15

Report date

2024-06-26

Voluntary/Mandated

Voluntary: Firm initiated

Location

Bonaduz, N/A, Switzerland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2020-2024