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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.
Dikunjungi: 10241
Jun 2021 : Initiation of FSCA (MY-FSN-RDS-CoreLab-2021-006) - cobas® 6500: possible sample mismatch software 2.3.0 – 2.3.6.
Dikunjungi: 7858
Jun 2021 : POC 21-021 RAPIDPoint 500 System Measurement Cartridges : Potential For Lactate Signal Carryover on RAPIDPoint 500 System Measurement Cartridges.
Dikunjungi: 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
Dikunjungi: 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)
Dikunjungi: 6250
Jun 2021 : Notification of Field Action: INGENIO 2 (ESSENTIO, PROPONENT) PACEMAKER, Ingenio 2 (Valitude, Valitude X4, Visionist, Visionist X4 CRT-P)
Dikunjungi: 3250
Jun 2021 : Field Safety Notification on Access CEA (FA-000602) : Duplicate lot numbers for current and expired Access CEA reagent packs.
Dikunjungi: 5308
Jun 2021 : CVG-22-Q1-04 Heartware Ventricular Assist System (HVAD) System : Notify customers on stop distribution and sale
Dikunjungi: 3582
Jun 2021 : Field Safety Notice - Ineffectiveness usage- Kangaroo Epump sets
Dikunjungi: 5452
Jun 2021 : FCA Report_CVG-22-Q1-02 Reveal LINQ with TruRhythm™ Insertable Cardiac Monitoring Systems
Dikunjungi: 8867
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Home
Pengenalan
Latar Belakang
Visi, Misi & Nilai Teras
Objektif
Hubungi Kami
Carta Organisasi
Code of Ethics and Conduct
Board of Directors
Top Management
Bahagian
Pejabat Ketua Eksekutif
Unit Komunikasi Korporat
Unit Undang-undang
Unit Integriti
Secretarial Unit
Bahagian Pendaftaran, Pelesenan Dan Penguatkuasaan
Post Market & Enforcement Division
Policy & Strategic Planning Division
International and Industry Affairs Division
Unit Pengurusan Dan Perkhidmatan
Soalan Lazim
Single License Policy Implementation
Pendaftaran, Pelesenan & Penguatkuasaan
Labelling of Medical Devices
Technical Evaluation
Hubungi
Borang Aduan Pelanggan
Kajian Kepuasan Pelanggan
Direktori Kakitangan
Dokumen
Perundangan
Surat Pekeliling
Dokumen Panduan
Garis panduan
Standard
General Directions
Strategic Plan
Persembahan Slide
Infographic
Organizational Anti Corruption Plan (OACP) MDA 2022 - 2026
Buletin MDA
Press Release
Media Coverage (Newspaper Cutting)
Customer Satisfaction Survey Result
Laporan Tahunan
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