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December 2021 : Corrective Action Notification FCO-02961-D : Single FOV Static PET reconstruction bug
Hits: 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
Hits: 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.
Hits: 11532
December 2021 : Field Safety Notice NC 3946 DEFIGARD Touch 7 (Initial Report) : Possible that a defibrillation shock cannot be delivered.
Hits: 4482
December 2021 : Field Safety Notice ICSMA-21-343-01 - SSO Password Vulnerability for Cardiology Products : Unauthorized access to application functions and patient data
Hits: 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.
Hits: 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
Hits: 7115
November 2021 : FSN-2021-013 DR0155M Thermo Scientific™ Campylobacter Test Kit: Auto-agglutinating in all the test latexes with + to ++ reactions.
Hits: 12093
November 2021 : FCA Notification - iDesign Advanced Wavescan Studio System : Patch installation due to potential cybersecurity vulnerability concerning the Windows Print Spooler Service.
Hits: 9060
November 2021 : FCA Notification - CATALYS™ Precision Laser System : Patch installation due to potential cybersecurity vulnerability concerning the Windows Print Spooler Service.
Hits: 12498
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Page 5 of 16
Home
Introduction
Background
Vision, Mission & Core Value
Functions
Contact Us
Organisation Chart
Code of Ethics and Conduct
Board of Directors
Top Management Team of MDA
Malaysian Leadership
Former CEO of MDA
Division
Chief Executive's Office
Corporate Communication Unit
Legal Unit
Integrity Unit
Secretarial Unit
Pre-Market Control Division
Post Market & Enforcement Division
Policy & Strategic Planning Division
International and Industry Affairs Division
Management and Service Unit
FAQ
Single License Policy Implementation
Registration, Licensing & Enforcement
Labelling of Medical Devices
Technical Evaluation
Contact Us
Customer Complaint Form
Customer Satisfaction Survey
Staff Directory
Documents
Legislation
Circular Letter
Guidance Document
Guideline
Standard
General Directions
Strategic Plan
Slide Presentation
Infographic
Organizational Anti Corruption Plan (OACP) MDA 2022 - 2026
Buletin MDA
Press Release
Media Coverage (Newspaper Cutting)
Customer Satisfaction Survey Result
Annual Report
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