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April 11, 2025
11
Apr

FDA Recall: Software defect can lead to under-delivery or over-delivery of insulin

April 11, 2025
Company: Tandem Diabetes Care, Inc. Date of Enforcement Report: 4/11/2025 Class I PRODUCT t:slim X2 Insulin Pump with Interoperable Technology Recall Number: Z-1519-2025 REASON: A software defect in Version 7.9 of the pump software for Tandem t:slim X2 and Tandem Mobi pumps, when used with Control IQ+ technology, will cause the pump to incorrectly interpolate...
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