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Type of Product	Medical Device
TGA Recall Reference	RC-2016-RN-00450-1
Product Name/Description	Hamilton-G5 and Hamilton -S1 Ventilators with software versions v2.41, v2.42 and v2.50 Product codes: 159001 & 159005 Multiple Serial Numbers ARTG Number: 113999
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	29/04/2016
Responsible Entity	AHC Solutions Pty Ltd
Reason/Issue	The analysis of a customer complaint has identified an issue related to suctioning with the use of the HAMILTON-G5 and HAMIL TON-S1 ventilators. After performing the suctioning manoeuvre, including disconnecting the patient, suctioning, and then reconnecting the patient, the preset pattern of ventilation may not continue as expected. Under certain conditions, a different ventilation mode than the operator selected Mode maybe applied; this situation can occur independent from the selected patient group (neonate, paediatric, or adult). This situation may occur if the ventilation mode changes during the pre-oxygenation phase. After the suctioning manoeuvre is finished and the patient is reconnected, the ventilation mode active before the pre-oxygenation phase is used. Under these conditions, the ventilation mode displayed by the Ventilator is not the same as the applied ventilation mode. In the worst case, the patient may be either hypo ventilated or hyperventilated.
Recall Action	Recall for Product Correction
Recall Action Instructions	AHC is providing instructions to deactivate the suctioning option on all affected ventilators until a software upgrade to version 2.60 has been installed. Users are advised to ensure there are alternative suction devices available. This action has been closed out on 19/02/2019
Contact Information	02 99809669 - AHC Solutions