Alert

Articles
Title	Hits
October 2021 : Field Safety Notice AX067/21/S : Missing regular reboot of the system may result in frozen vital signs	8797
September 2021 : Urgent Product Correction FA29SEP2021 ARCHITECT ARCHITECT System software v9.45/9.50	4320
September 2021 : FSCA LASW 21-02 Aptio by Inpeco and FlexLab Automation : Aptio Automation Firmware (FW) for the ADVIA Centaur XP/XPT Interface Module may lead, in specific and rare cases, to an incorrect association of test result(s) to sample ID.	7374
September 2021 : 2021-IGT-PUN-010 (FCO72300030) - Firmware Upgrade for Intuis System	4600
September 2021 : FSCA ACHC 21-14 ADVIA and Atellica UCFP carryover : Falsely Depressed Enzymatic Hemoglobin A1c Results due to Reagent Carryover from the Urinary/Cerebrospinal Fluid Protein (UCFP) Assay.	11108
September 2021 : Field-Corrective Action Notification 20001103083 : Digital Linear Accelerator - For service user: precautions to be taken when handling diode D1	5253
September 2021 : Corrective action reporting for FMI 32081 : Mounting issue for LullabyTMResus Plus/Prime dovetailmounts ontoLullabyTMWarmer side rails	4190
September 2021 : Product Field Corrective Action PR 2795031 - Stryker NAV3/NAV3i Platforms : Microsoft Windows Print Spooler Vulnerabilities	4259
September 2021 : Notification of Initiation of FSCA (MY-FSN-RDS-Molecular Lab-2021-011) - cobas® EGFR Mutation Test v2: Potential for False Mutation Detected results for exon20 Insertion.	9997
September 2021 : Important Safety Notice VISTA 120 CMS SpO2 Alarm : Software Patch for Vista CMS required	4513

Title

Hits

October 2021 : Field Safety Notice AX067/21/S : Missing regular reboot of the system may result in frozen vital signs

8797

September 2021 : Urgent Product Correction FA29SEP2021 ARCHITECT ARCHITECT System software v9.45/9.50

4320

September 2021 : FSCA LASW 21-02 Aptio by Inpeco and FlexLab Automation : Aptio Automation Firmware (FW) for the ADVIA Centaur XP/XPT Interface Module may lead, in specific and rare cases, to an incorrect association of test result(s) to sample ID.

7374

September 2021 : 2021-IGT-PUN-010 (FCO72300030) - Firmware Upgrade for Intuis System

4600

September 2021 : FSCA ACHC 21-14 ADVIA and Atellica UCFP carryover : Falsely Depressed Enzymatic Hemoglobin A1c Results due to Reagent Carryover from the Urinary/Cerebrospinal Fluid Protein (UCFP) Assay.

11108

September 2021 : Field-Corrective Action Notification 20001103083 : Digital Linear Accelerator - For service user: precautions to be taken when handling diode D1

5253

September 2021 : Corrective action reporting for FMI 32081 : Mounting issue for LullabyTMResus Plus/Prime dovetailmounts ontoLullabyTMWarmer side rails

4190

September 2021 : Product Field Corrective Action PR 2795031 - Stryker NAV3/NAV3i Platforms : Microsoft Windows Print Spooler Vulnerabilities

4259

September 2021 : Notification of Initiation of FSCA (MY-FSN-RDS-Molecular Lab-2021-011) - cobas® EGFR Mutation Test v2: Potential for False Mutation Detected results for exon20 Insertion.

9997

September 2021 : Important Safety Notice VISTA 120 CMS SpO2 Alarm : Software Patch for Vista CMS required

4513

Medical Device Authority (MDA),
Ministry of Health Malaysia,
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Block 3547, Persiaran APEC,
63000 Cyberjaya, Selangor, MALAYSIA

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Last Updated: 09 December 2025.