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Tandem Diabetes Care, Inc.: t:slim X2 Insulin Pump with Interoperable

Reward FDA device recall — free correction, repair, or replacement from manufacturer or authorized retailer

Recall reason: 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.. Recalled by Tandem Diabetes Care, Inc.. Distribution: International distribution to the country of Israel.. Classification (Class II — potential health risk). Affected lots/dates: Tandem t:slim Mobile App, Android Software Version 2.9.1 UDI-DI code: 00389152470641 Serial Numbers / Cell Phone OS: 116. Contact the manufacturer or the retailer where you purchased this device to arrange for a free correction, repair, or replacement.

Reward FDA device recall — free correction, repair, or replacement from manufacturer or authorized retailer
Category Product Recalls & Refunds
Location National
Eligibility U.S. consumers who own or purchased the recalled medical device. Contact the manufacturer or the retailer/pharmacy where you purchased it to arrange for a free correction, repair, or replacement. Have the model number ready if possible.
Source Official Source ↗
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