Hamilton Medical AG Recall 91925
Description: HAMILTON-C6, REF: 160021
Hamilton Medical AG Recall 91925 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1429-2023 |
| Event ID | 91925 |
| Event Description | HAMILTON-C6, REF: 160021 |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the states of CA, MA, ID, NC, GA, FL, NV, PA, MO, KS, SC, NY, NM, WY, VA. |
| Quantity | 103 |
| Recall Reason | Software error causes, safety ventilation, in which ventilation continues in the "safety ventilation" mode with audible/visible alarm - patient inputs are not monitored, if the following coincide 1) A mode change to an adaptive mode (ASV, APVcmv, APVsimv, INTELLiVENT-ASV, (S)CMV+, SIMV+), and 2) The controller and/or humidifier is connected to the ventilator and is operational. |
| Device Classification | 20230503 |
| Device Code Info | Software Version: 1.2.1, UDI-DI: 07630002808590 |
| Center Classification Date | 20230425 |
| Recall Initiation Date | 20230314 |
| Recalling Firm | Hamilton Medical AG |
| Initial Notification | Letter |
| Similar To |