Hamilton C6 Ventilator Recalled Due to Mechanical Circuit Board Defect
Hamilton Medical is recalling 1,040 Hamilton C6 ventilators nationwide due to a mechanical defect in the printed circuit board that may cause device failure or interruption of ventilation.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I designation; the PCB defect may cause ventilator failure at startup or loss of ventilation during use, representing a serious risk to patients dependent on continuous respiratory support.
Plain-English summary
Hamilton Medical AG is recalling 1,040 Hamilton C6 ventilators (Model 160021) due to a mechanical defect on the printed circuit board. The C6 is intended to provide positive pressure ventilatory support to adults, pediatric patients, and optionally infants and neonates.
The defect results from the PCB separating process and may cause the ventilator to fail at startup or to enter an ambient state during use, resulting in interruption of ventilation.
The affected ventilators were distributed nationwide. Those with serial numbers in the specified ranges (13636–13950, 13966–14753) and certain additional serial numbers may be affected. Patients and healthcare providers should contact Hamilton Medical immediately for remediation options.
The recalled product
- 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.
- Manufacturer
- Hamilton Medical AG
- Hazard
- mechanical-defect
- equipment-failure
- loss-of-ventilation
Distribution
Distributed nationwide across the United States.
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