Recall Z-2621-2025 ยท QFG Alternate Controller Enabled Insulin Infusion Pump
Tandem Diabetes Care, Inc.
t:slim X2 Insulin Pump with Interoperable Technology (with Tandem t:slim mobile app)
| Date | Sep 24, 2025 (initiated Jul 3, 2025) |
| Status | Open, Classified |
| 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. |
| Root cause | Software design |
| Action | On 07/03/2025, the firm sent an "URGENT FIELD SAFETY NOTICE" it distributor to notify customers that users operating an Android phone with language setting set as Hebrew may experience a blank screen on the mobile application during the initial pairing sequence. The language setting must be set to English for the pairing sequence to work successfully. However, if users set their language back to a right-to-left language after pairing, or do not encounter the initial issue, the mobile application will display discrepancies. This discrepancy may cause a user to make incorrect therapy decisions |
| Quantity | 19 |
| Distribution | International distribution to the country of Israel. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K232380 | t:slim X2 Insulin Pump with Interoperable Technology Tandem Diabetes Care, Inc., Nov 3, 2023 |