t:slim X2 Insulin Pump with Interoperable Technology (with Tandem t:slim mobile app)
an app defect that occurs when the phone is set to a right-to-left language, which causes app-pump pairing issues and graphical defects, which can potentially lead to incorrect therapy decisions and subsequent hypoglycemia or hyperglycemia.
International distribution to the country of Israel.
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2621-2025