Recall Z-1429-2023— Hamilton Medical AG
Class II · Ongoing
Class II FDA medical device recall by Hamilton Medical AG, initiated 2023-03-14. It names one FDA 510(k) clearance: K201658. Product: HAMILTON-C6, REF: 160021. 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..
- Recalling firm
- Hamilton Medical AG
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-03-14
- Firm location
- Bonaduz, N/A, Switzerland
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
HAMILTON-C6, REF: 160021
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.