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.
Recall
- Recall Number
- Z-2328-2025
- Event Number
- 97079
- Firm
- Hamilton Medical AG Parc Industrial Vial 10 Domat/Ems Switzerland
- FEI Number
- 3014766741
- Product Code
- CBK
- Status
- Open, Classified
- Root Cause
- Equipment maintenance
- Initiated
- June 3, 2025
- Posted
- August 19, 2025
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.
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.
URGENT: Medical Device Correction letters were emailed to customers on 06/06/2025, 06/20/2025, and 07/07/2025, informing them that due to damage to the capacitor in the ESM-Board within the Hamilton-C6 ventilator the capacitor could, over time, lead to a loss of its function due to oxidation of similar degradation processes. Customers are instructed to: 1. Review their Hamilton-C6 ventilators and check for the serial number within the scope mentioned in the letter. 2. for affected ventilators must have the ESM-Boards replaced. The replacement will be organized by the local partner as per servicing protocol. Note - the Hamilton-C6 ventilators do not need to be removed from use/service. These devices were tested prior to release and no test will be able to detect if the ESM board will fail in the future. 3. Keep the recall notice within the respective ventilator's data records. For questions or assistance, contact Technical Support at 1-800-426-6331 option 2 or email [email protected]
US Nationwide distribution.
1040 systems