Hamilton Medical AG: Device Recall

Recall Details

Recall Number

Z-2328-2025

Classification

Class I

Product Type

Device

Recalling Firm

Hamilton Medical AG

Status

Ongoing

Date Initiated

06/03/2025

Location

Domat/Ems, N/A, Switzerland

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

1040 systems

Reason for Recall

A mechanical defect on a printed circuit board (PCB) as a result of PCB separating process. This defect might cause the ventilator to either fail at startup (no patient involvement) or during the use of the device enter ambient state, resulting in an interruption of ventilation.

Product Description

Hamilton C6 REF 160021 (ESM Board PN 10144626 UDI-DI code: 76300028PN160021ZW Hamilton C6 is a ventilator intended to provide positive pressure ventilatory support to adults and pediatrics and optionally infants and neonates.

Distribution Pattern

US Nationwide distribution.

Other Recalls by Hamilton Medical AG

• Class I: Dangerous 06/26/2025
  Ventilator coaxial breathing circuit may have a crack in blue tubing, which is used to deliver fresh gas to the patient. The crack will compromise inspiratory and expiratory flows, leading to partial or complete rebreathing of exhaled gases, which could lead to acute hypercapnia, respiratory acidosis, and if unrecognized organ dysfunction.
• Class I: Dangerous 05/15/2024
  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.

View all recalls by Hamilton Medical AG →