Medtronic is recalling 26 units of the Model 97745 Controller used with Intellis Neurostimulators (Models 97715 and 97716). These devices were distributed in South Korea and Turkey with incorrect firmware that does not support the local user interface language. This defect could prevent users from effectively using the device interface in their primary language.
The lack of local language support on the controller's user interface may lead to user error or the inability to properly adjust neurostimulation settings, potentially impacting the effectiveness of the medical treatment.
Contact healthcare provider or manufacturer.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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