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Hamilton C6 REF 160021 (ESM Board PN 10144626 UDI-DI code: 76300028PN160021ZW Hamilton C6 is ...

FDA Recall #Z-2328-2025 — Class I — June 3, 2025

Recall #Z-2328-2025 Date: June 3, 2025 Classification: Class I Status: Ongoing

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.

Recalling Firm

Hamilton Medical AG — Domat/Ems, N/A

Classification

Class I — Reasonable probability of serious adverse health consequences or death.

Product Type

Devices

Product Quantity

1040 systems

Distribution

US Nationwide distribution.

Code Information

Model/Catalog Number: 160021 ESM board Part Number: 10144626 GTIN: 07630002808590 UDI-DI: 76300028PN160021ZW Affected SN range: 13636 till 13950 and 13966 till 14753 13797 13801 13806 13855 13865 13981 13988 13989 14012 14015 14019 14034 14035 14042 14052 14054 14102 14109 14112 14113 14114 14115 14116 14119 14120 14121 14122 14123 14124 14126 14127 14128 14163 14168 14169 14170 14172 14173 14175 14177 14187 14188 14189 14195 14197

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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