Recall Z-2141-2023 ยท CBK Ventilator, Continuous, Facility Use
Hamilton Medical, Inc.
HAMILTON C2 Ventilator Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates
| Date | Jul 21, 2023 (initiated Jun 15, 2023) |
| Status | Open, Classified |
| Reason | Due to a software anomaly after approximately 91 days of cumulative use, the ventilator may stop and enter the ambient mode without prior notice. |
| Root cause | Software design |
| Action | On 06/15/2023, the firm sent via email an "URGENT Medical Device Correction" Letter to customers informing them that, affected HAMILTON-C2/C3/C1/T1 ventilators which are used for long-term ventilation in neonatal group will switch to the "Ambient State" if the ventilation time is exceeding 91 days. During the "Ambient State" the ventilator will alarm audibly and visually displayed on the screen and would result in no active ventilation being provided to patients. Instructions for Customers: Required user actions if failure occurs: In such a case, perform the following actions steps: 1. Provi |
| Quantity | 399 systems |
| Distribution | U.S.: Alabama Alaska Arizona Arkansas California Colorado Connecticut Delaware Florida Georgia Hawaii Idaho Illinois Indiana Iowa Kansas Kentucky Louisiana Maine Maryland Massachusetts Michigan Minnesota Mississippi Missouri Montana Nebraska Nevada New Hampshire New Jersey New York North Carolina No |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K121225 | HAMILTON-C2 Hamilton Medical AG, Nov 16, 2012 |