K
katastic2908
Hello, Please help me, I am so tired of combing the internet for vague answers.
We have a Class II device, this device is electronic and is used in conjunction with other manufacturers products, for example with patient return electrode pads that are made by several different manufacturers.
We have recently discovered that our device is not compatible with one manufacturers patient return electrode pads. We have a fix for that and want to offer it free of charge to the customers that have already purchased the device. We did not state in the IFU or marketing literature all of the compatible patient return electrode pads, only that the system will only work with compatible products.
We would like to offer it to the customers that purchased the device already the option to return the product so we could modify it so it works with this particular patient return electrode pads (while also still working with all of the other pads), but as long as they don't use that particular set of pads the device works as intended with all other pads we've tested.
Would this be considered a Removal, Market withdrawal, or something else?
I don't feel it would be reportable as there is no safety risks or violations.
Please help me, I am at my wits end.
We have a Class II device, this device is electronic and is used in conjunction with other manufacturers products, for example with patient return electrode pads that are made by several different manufacturers.
We have recently discovered that our device is not compatible with one manufacturers patient return electrode pads. We have a fix for that and want to offer it free of charge to the customers that have already purchased the device. We did not state in the IFU or marketing literature all of the compatible patient return electrode pads, only that the system will only work with compatible products.
We would like to offer it to the customers that purchased the device already the option to return the product so we could modify it so it works with this particular patient return electrode pads (while also still working with all of the other pads), but as long as they don't use that particular set of pads the device works as intended with all other pads we've tested.
Would this be considered a Removal, Market withdrawal, or something else?
I don't feel it would be reportable as there is no safety risks or violations.
Please help me, I am at my wits end.