Tandem Diabetes Care recalls 19 units of the t:slim X2 insulin pump with interoperable technology distributed internationally, including Israel. An app defect occurs when the phone uses a right-to-left language and can cause app-pump pairing problems and graphical defects. Patients should stop using the device immediately and follow the manufacturer’s recall instructions.
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.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Tandem Diabetes Care, Inc. or your healthcare provider for instructions. Notification method: Letter
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The t:slim X2 insulin pump with interoperable technology is used by people with diabetes to manage insulin delivery through a paired mobile app.
A right-to-left language setting can disrupt app-pump pairing and create display errors, risking incorrect dosing decisions.
This recall is not described as part of a broader industry pattern in the provided data.
The issue could lead to incorrect therapy decisions and potential hypo- or hyperglycemia, requiring clinical follow-up.
Recall notice and device identifiers are provided by Tandem Diabetes Care and the FDA enforcement database.
Remediation timelines are not specified; typical recall processes may take several weeks to finalize refunds or replacements.
Keep the recall notice, device serial numbers, app version, and all correspondence with the manufacturer for records.
Model numbers: Tandem t:slim Mobile App; Android Software Version 2.9.1; t:slim X2 Insulin Pump. Where sold: International distribution, including Israel. When sold: Unknown. Price: Unknown.
No injuries or incidents have been reported.
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