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Jun 2021 : [Important Product Correction Notification] [TC2021-175] - Unexpected Grip Arm & Pipettor Movement in Maintenance Mode on the ORTHO VISIONT and ORTHO VISIONT Max Analyzers
Hits: 6772
Jun 2021 : Field Safety Notice FSN-2021-0006 CT0223B AMC30 Amoxycillin / Clavulanic Acid Antimicrobial Susceptibility Discs
Hits: 2963
Jun 2021 : Initial Report for 2021-CC-EC-002 - Philips HeartStart Intrepid Monitor/Defibrillator (867172) - Possible interference with other monitoring devices
Hits: 8099
Jun 2021 : FCA_DTG_Intuitive Surgical ISIFA2021-01-C : da Vinci® S/Si Harmonic Ace Reprocessing Instructions For Use (IFU)
Hits: 8511
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.
Hits: 9966
Jun 2021 : Initiation of FSCA (MY-FSN-RDS-CoreLab-2021-006) - cobas® 6500: possible sample mismatch software 2.3.0 – 2.3.6.
Hits: 7654
Jun 2021 : POC 21-021 RAPIDPoint 500 System Measurement Cartridges : Potential For Lactate Signal Carryover on RAPIDPoint 500 System Measurement Cartridges.
Hits: 3441
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
Hits: 3197
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)
Hits: 5822
Jun 2021 : Notification of Field Action: INGENIO 2 (ESSENTIO, PROPONENT) PACEMAKER, Ingenio 2 (Valitude, Valitude X4, Visionist, Visionist X4 CRT-P)
Hits: 2991
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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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