Recall Z-2328-2025— Hamilton Medical AG

Name: FDA recall Z-2328-2025
Creator: U.S. Food and Drug Administration
Published: 2025-06-03

Class I · Ongoing

Class I FDA medical device recall by Hamilton Medical AG, initiated 2025-06-03. It names one FDA 510(k) clearance: K201658. Product: 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.. Reason: 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..

Recalling firm: Hamilton Medical AG
Classification: Class I
Status: Ongoing
Initiated: 2025-06-03
Firm location: Domat/Ems, N/A, Switzerland

510(k) clearances named in this recall

1 on FDA's record

K201658 — Hamilton-C6Hamilton Medical AG·cleared 2020-12-11

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.