Tandem Diabetes Care, Inc. is recalling approximately 19 units of its Tandem t:slim Mobile App (Android Software Version 2.9.1) used with the t:slim X2 Insulin Pump. The recall affects users in Israel who have their mobile phones set to a right-to-left language (such as Hebrew or Arabic). A software defect causes the app to fail to pair correctly with the pump and creates graphical errors, which can cause users to make incorrect treatment decisions. Consumers should consult their healthcare provider for instructions on managing their insulin therapy while using the pump without the app.
The software defect can lead to incorrect pump therapy decisions and graphical display errors. This poses a significant risk of hypoglycemia (dangerously low blood sugar) or hyperglycemia (dangerously high blood sugar) if a user receives too much or too little insulin based on faulty app information.
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Affected when phone is set to a right-to-left language. Affected phone models include Google Pixel 8 Pro, Google Pixel 6 Pro, Google Pixel 9, Samsung SM-S901E, Samsung SM-A346E, Samsung SM-G780G, Samsung SM-S928B, Samsung SM-A546E, Xiaomi 2407FPN8EG, Samsung SM-S711B, Samsung SM-N980F, Samsung SM-S926B, Samsung SM-S916B, and realme RMX3241.
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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