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October 2021 : Field Safety Notification FA-21066 on COULTER 4C-ES Cell Controls : Issue with flagging on White Blood Cell (WBC) values and differential parameters for COULTER 4C-ES Cell Controls.
Hits: 4618
October 2021 : Important Product Correction Notification [TC2021-254] - MOD 52 Software Anomalies on ORTHO VISION and ORTHO VISION Max Analyzers
Hits: 3710
October 2021 : FMI 85459 : Potential to display incomplete patient imaging study in Centricity Universal Viewer Zero Footprint configured with a Centricity PACS back end.
Hits: 4068
October 2021 : Field Safety Notice MI506/21/S : Biograph, Biograph Truepoint, Biograph MCT - Improper use of the Patient Handling System (PHS) Pallet/Foot Extension
Hits: 7901
October 2021 : FMI 38008 : Safety issues in Centricity High Acuity Critical Care (CHA CC) and Centricity High Acuity Anesthesia (CHA A)
Hits: 8234
October 2021 : FMI 25500 : Potential SmartStep Dose display error on Revolution CT, Revolution CT ES, Revolution Apex, and Revolution CT with Apex Edition Systems
Hits: 3872
October 2021 : Initial Report for CR 2021-IGT-BST-020 Allura Xper and Azurion systems - Wireless footswitch lost connection
Hits: 4080
October 2021 : Field Safety Notice AX070/21/S : Potential software issue on Artiszee/Q/Q.zen systems with software version VD12
Hits: 4807
October 2021 : Field Corrective Action Notification 80601BTP002 : Mirroring of Applicator Model may occur in Oncentra® Brachy
Hits: 8508
October 2021 : CR 2021-PD-DXR-012 : CombiDiagnost R90/ProxiDiagnost N90 - Missing Warning Label on the Monitor.
Hits: 8392
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Home
Introduction
Background
Vision, Mission & Core Value
Functions
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
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)
Annual Report
Customer Satisfaction Survey
Customer Satisfaction Survey Result
Customer Satisfaction Survey Report
Integrity Information
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