Reported Aug 27, 2025 · Ongoing
Hamilton C6 REF 160021 (ESM Board PN 10144626 UDI-DI code: 76300028PN160021ZW Hamilton C6 is a ventilator intended to…
Hamilton Medical AG
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Hamilton Medical AG · Parc Industrial Vial 10 · Domat/Ems, N/A · N/A
Is this the product you have?
- Hamilton C6 REF 160021 (ESM
- Board PN 10144626 UDI-DI code76300028PN160021ZW Hamilton C6 is a ventilator intended to provide positive pressure ventilatory support to adults and pediatrics and optionally infants and neonates
- Lot codes and dates
- Model/Catalog Number160021
- ESM board Part Number10144626
- GTIN07630002808590
- UDI-DI76300028PN160021ZW
- Affected SN range13636 till 13950 and 13966 till
14753137971380113806138551386513981139881398914012140151401914034140351404214052140541410214109141121411314114141151411614119141201412114122141231412414126141271412814163141681416914170141721417314175141771418714188141891419514197
- Amount recalled
- 1040 systems
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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