Hamilton Medical AG: Medical Device Recall in 2024 - (Recall #: Z-2020-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

Ventilator HAMILTON-C6, PN: 160021

Product Classification:

Class I

Date Initiated: May 15, 2024

Date Posted: June 26, 2024

Recall Number: Z-2020-2024

Event ID: 94671

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.

Status: Ongoing

Product Quantity: 68

Code Information:

UDI: 07630002808590, Software Versions: SW v1.1.4, SW v1.1.5, SW v1.1.6

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated