Recall Z-0267-2023 ยท CBK Ventilator, Continuous, Facility Use
Hamilton Medical AG
Hamilton-C6
| Date | Nov 18, 2022 (initiated Sep 22, 2022) |
| Status | Open, Classified |
| Reason | Due to a malfunction related to the backlight on the ventilator screen. The screen goes black for approximately 2-3 seconds, but it brightens up again when the backlight switches on again. |
| Root cause | Under Investigation by firm |
| Action | On 10/19/2022, Hamilton Medical, Inc. sent an "URGENT - Medical Device Correction" Letter via email to customers informing them the firm had received a complaint report associated with the backlight of the HAMILTON C-6 display failing. The failure is attributed to a reset of the HMI controller reset with causes the display to fail for 2-3 seconds. Hamilton Medical is notifying customer that this failure does not affect or interrupt the device's ventilation function. Customers are instructed to: -Sign the enclosed sheet confirming that they have received and understood this Medical Device Co |
| Quantity | 8,229 total systems worldwide (U.S. 443 systems) |
| Distribution | U.S. Nationwide distribution including in the states of CA, FL, GA, ID, IN, KS, KY, MA, MI, MO, NV, NM, NY, NC, OH, PA, Puerto Rico, SC, TX, VA, WA, WV, WI, and WY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K201658 | Hamilton-C6 Hamilton Medical AG, Dec 11, 2020 |