Hamilton Medical AG: Medical Device Recall in 2023 - (Recall #: Z-1429-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

HAMILTON-C6, REF: 160021

Product Classification:

Class II

Date Initiated: March 14, 2023

Date Posted: May 3, 2023

Recall Number: Z-1429-2023

Event ID: 91925

Reason for Recall:

Software error causes, safety ventilation, in which ventilation continues in the "safety ventilation" mode with audible/visible alarm - patient inputs are not monitored, if the following coincide 1) A mode change to an adaptive mode (ASV, APVcmv, APVsimv, INTELLiVENT-ASV, (S)CMV+, SIMV+), and 2) The controller and/or humidifier is connected to the ventilator and is operational.

Status: Ongoing

Product Quantity: 103

Code Information:

Software Version: 1.2.1, UDI-DI: 07630002808590

Distribution Pattern:

US Nationwide distribution in the states of CA, MA, ID, NC, GA, FL, NV, PA, MO, KS, SC, NY, NM, WY, VA.

Voluntary or Mandated:

Voluntary: Firm initiated