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FDAMay 15, 2024device

Ventilator HAMILTON-C6, PN: 160021

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Ongoing

Brands named

hamilton medical aghamiltonhamilton medical

UPCs

07630002808590

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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Ventilator HAMILTON-C6, PN: 160021 — Recall Details · AllClear