HAMILTON-C6, REF: 160021
Reported: May 3, 2023 Initiated: March 14, 2023 #Z-1429-2023
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.
Details
- Recalling Firm
- Hamilton Medical AG
- Units Affected
- 103
- Distribution
- US Nationwide distribution in the states of CA, MA, ID, NC, GA, FL, NV, PA, MO, KS, SC, NY, NM, WY, VA.
- Location
- Bonaduz, N/A
Frequently Asked Questions
What product was recalled? ▼
HAMILTON-C6, REF: 160021. Recalled by Hamilton Medical AG. Units affected: 103.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 3, 2023. Severity: Moderate. Recall number: Z-1429-2023.
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