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December 2021 : Corrective Action Notification FCO-02961-D : Single FOV Static PET reconstruction bug
Dikunjungi: 3910
December 2021 : Notification on Initial Report for CR-2021-IGT-PUN-011 (FCO71800101) - Zenition 70 Wireless Footswitch Safety Notification : Wireless footswitch connection issues causing interruption of live Fluoroscopy imaging or exposure
Dikunjungi: 3796
December 2021 : FSN : QIAcube Connect MDx Instrument REF 9003070 - issue with the text contained within several protocols which run on the QIAcube® Connect MDx instrument.
Dikunjungi: 11532
December 2021 : Field Safety Notice NC 3946 DEFIGARD Touch 7 (Initial Report) : Possible that a defibrillation shock cannot be delivered.
Dikunjungi: 4482
December 2021 : Field Safety Notice ICSMA-21-343-01 - SSO Password Vulnerability for Cardiology Products : Unauthorized access to application functions and patient data
Dikunjungi: 4725
December 2021 : Initial Reporting FA 21072 : Field Safety Notification on AU/DxC AU Magnesium - IFU update due to lipemic interference for the Magnesium serum application failed to meet the performance specification.
Dikunjungi: 7402
November 2021 : Customer Safety Information (CSI) for Field Safety Corrective Action FCA AX077/21/S | FSN AX078/21/S, AX081/21/S : ComboBox does no longer login automatically after several reboots. Calculation of Cardiac Output (Thermodilution method) on
Dikunjungi: 7115
November 2021 : FSN-2021-013 DR0155M Thermo Scientific™ Campylobacter Test Kit: Auto-agglutinating in all the test latexes with + to ++ reactions.
Dikunjungi: 12093
November 2021 : FCA Notification - iDesign Advanced Wavescan Studio System : Patch installation due to potential cybersecurity vulnerability concerning the Windows Print Spooler Service.
Dikunjungi: 9060
November 2021 : FCA Notification - CATALYS™ Precision Laser System : Patch installation due to potential cybersecurity vulnerability concerning the Windows Print Spooler Service.
Dikunjungi: 12498
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Utama
Pengenalan
Latar Belakang
Visi, Misi & Nilai Teras
Objektif
Hubungi Kami
Carta Organisasi
Code of Ethics and Conduct
Board of Directors
Top Management Team of MDA
Malaysian Leadership
Former CEO of MDA
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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