Recall Z-2328-2025 ยท CBK Ventilator, Continuous, Facility Use
Hamilton Medical AG
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.
| Date | Aug 19, 2025 (initiated Jun 3, 2025) |
| Status | Open, Classified |
| 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. |
| Root cause | Equipment maintenance |
| Action | 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 serv |
| Quantity | 1040 systems |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K201658 | Hamilton-C6 Hamilton Medical AG, Dec 11, 2020 |