Company: Tandem Diabetes Care, Inc. Date of Enforcement Report: May 06, 2024 Class I PRODUCT t:connect mobile app used in conjunction with t:slim X2 insulin pump with Control-IQ technology version 2.7 or later /UDI: 00850006613274 Recall Number: Z-1609-2024 REASON: During normal use, the mobile app version 2.7 may crash and be automatically relaunched by the...Read More

Company: Medtronic Navigation, Inc. Date of Enforcement Report: 5/9/2024 Class I PRODUCT Stealth S8 Clinical Software Application, REF: 9735762, CE0344, Rx Only. Used in the StealthStation System as an aid for locating anatomical structures in either open or percutaneous neurosurgical procedures. Recall Number: Z-1776-2024 REASON: Due to a software issue, there is the potential for...Read More

WARNING LETTER CMS# 675673 Cue Health, Inc. San Diego, CA May 9, 2024 Inspection Dates: on 10 dates between October 17, 2023 and November 3, 2023. Inspection Issue(s): “not complying with the following Conditions of Authorization in the Letters of Authorization for EUA200248 and EUA210180. For example: Evidence obtained during the inspection demonstrated that your...Read More