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November 2021 : Field Safety Notice CT050/21/S | Field Corrective Action CT049/21/S : SOMATOM GO.TOP - Remotely software update due to scanning workflow interruptions and unexpected user notifications
Hits: 3013
November 2021 : Field Corrective Action CT020/21/S : Update affected systems with SW-Version syngo CT VB20 in the installed Base, with or without syngo CT VB20 SP1 or SP2 or SP3 or SP4 to syngo CT VB20 SP5
Hits: 6305
November 2021 : Field Safety Notice CT067/21/S : Possible degradation of image quality in head scans when using the CT system.
Hits: 8219
November 2021 : FA1183 Wireless Recharger (WR9200, WR9220) Unresponsive
Hits: 3984
November 2021 : Field Corrective Action R-2021-004 : NEXADIA monitor - Software Update
Hits: 4560
November 2021 : Urgent Medical Device Correction FA1210 : Puritan Bennett™ 980 Series Ventilator Reverse Polarity (C103 Capacitor)
Hits: 6919
November 2021 : Field Corrective Action Notification From Thermo Scientific Microbiology Sdn. Bhd. - R30163701 Thermo Scientific™ Remel™ Shigella dysenteriae polyvalent, FSN-2021-012 : R30163701 lot 2971158 is not performing to IFU criteria
Hits: 6974
November 2021 : Reporting of FSCA 022021 - Ossur Miami J Select : Addtional User Instructions & Safety Warnings
Hits: 3844
November 2021 : Field Safety Notice CT035/21/S | Field Corrective Action CT026/21/S : SOMATOM PERSPECTIVE/SOMATOM SCOPE POWER - Sporadic problems with the current software may result in scanning workflow interruptions.
Hits: 5032
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: 3877
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Home
Introduction
Background
Vision, Mission & Core Value
Functions
Contact Us
Organisation Chart
Code of Ethics and Conduct
Board of Directors
Top Management
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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