Urgent Medical Device Correction.

We have an update to a previous recall regarding a malfunction with our HAMILTON-T1/C1/C2/C3 ventilators when used long-term in neonatal patient groups. If an affected device is used accumulatively for 91 days without restarting, the device will switch to an "Ambient State" and, therefore, stop ventilation. This update pertains specifically to a resolution for the malfunction occuring with a HAMILTON-C3 ventilator.

Action required by device operators:

Review the list of affected devices in the link below. For any serial numbers in your possession, check the installed software version of the ventilator by going to "System" and selecting the "Info" window. You should conduct the software update and upgrade the affected HAMILTON-C3 devices to SW version 2.0.11 or higher as soon as possible.

By filling out the form below, I confirm that I have received and noted this Medical Device Correction, stating that there is a potential issue with the reporting of battery life of the HAMILTON-C3 ventilator. I will follow the instructions regarding the malfunction. 

The entire Medical Device Correction and list of affected devices can be viewed by clicking on the respective buttons below.