Hamilton Medical recalls C6 ventilators with software version 1.2.1 due to safety ventilation mode not monitoring patient inputs, risking undetected issues during certain settings.
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.
Hamilton Medical is recalling C6 ventilators with software version 1.2.1 because a software error causes the safety ventilation mode to not monitor patient inputs. This could lead to undetected issues if specific settings and connected devices are used.
The software error causes the ventilator to stay in a safety ventilation mode that doesn't monitor patient inputs. If the ventilator is switched to adaptive modes (like ASV or APV) and connected to a humidifier or controller, the system may not detect problems, potentially leading to undetected issues.
Healthcare providers using Hamilton C6 ventilators with software version 1.2.1 are most at risk. Patients on ventilators with this specific software version could be affected if the ventilator is used with certain settings and connected devices.
Check for the model name 'Hamilton C6' and software version 1.2.1. The unique device identifier (UDI-DI) 07630002808590 is also associated with this recall.
Verify the software version on your Hamilton C6 ventilator; if it is 1.2.1, it is affected.
The recall is for a software error that could cause safety ventilation mode to not monitor patient inputs, but it does not cause immediate harm. Using the ventilator with specific settings and connected devices may lead to undetected issues.
Check for the model name 'Hamilton C6' and software version 1.2.1. The unique device identifier (UDI-DI) 07630002808590 is also associated with this recall.
The recall does not specify a remedy, so contact Hamilton Medical directly for guidance on next steps.
We’ve drafted a message you can send Hamilton Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1429-2023 — Hamilton Medical Hamilton Medical Hello, I own a Hamilton Medical that is covered by recall Z-1429-2023 from Hamilton Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
