Alert

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Title	Hits
Jun 2021 : Corrective action reporting for FMI 36149 : CARESCAPE PDM – Masimo SpO2 Saturation Values can become frozen after an extended length of usewithout a power down.	Hits: 10241
Jun 2021 : Initiation of FSCA (MY-FSN-RDS-CoreLab-2021-006) - cobas® 6500: possible sample mismatch software 2.3.0 – 2.3.6.	Hits: 7858
Jun 2021 : POC 21-021 RAPIDPoint 500 System Measurement Cartridges : Potential For Lactate Signal Carryover on RAPIDPoint 500 System Measurement Cartridges.	Hits: 3672
Jun 2021 : Corrective action reporting for FMI 34118 : URGENT MEDICAL DEVICE CORRECTION - Turbine Over temperature alarm/failure,a buildup of PEEP higher than set values, and Plateau Pressure inaccuracy could occur on Siaretron 4000T and Falco 202 Evo Ven	Hits: 3432
Jun 2021 : Field Safety Notice 92705305-FA – High Battery Impedance May Initiate Safety Mode in INGENIO™, VITALIO™, and ADVANTIO™ pacemakers and INLIVEN™, INTUA™, and INVIVE™ cardiac resynchronization therapy pacemakers (CRT-Ps)	Hits: 6249
Jun 2021 : Notification of Field Action: INGENIO 2 (ESSENTIO, PROPONENT) PACEMAKER, Ingenio 2 (Valitude, Valitude X4, Visionist, Visionist X4 CRT-P)	Hits: 3250
Jun 2021 : Field Safety Notification on Access CEA (FA-000602) : Duplicate lot numbers for current and expired Access CEA reagent packs.	Hits: 5307
Jun 2021 : CVG-22-Q1-04 Heartware Ventricular Assist System (HVAD) System : Notify customers on stop distribution and sale	Hits: 3582
Jun 2021 : Field Safety Notice - Ineffectiveness usage- Kangaroo Epump sets	Hits: 5452
Jun 2021 : FCA Report_CVG-22-Q1-02 Reveal LINQ with TruRhythm™ Insertable Cardiac Monitoring Systems	Hits: 8867