| No | Date received | Affected Medical Device | MDA Reference No. | MDA Registration No. |
Local Establishment Contact Detail | Copy of FSN |
|---|---|---|---|---|---|---|
| 1 | 2025-06-11 | AZURION 3 | MDA/FCA/P1318-19018758-2025 | GC99381544218 | PHILIPS MALAYSIA SDN BERHAD LEVEL 9, MENARA AXIS, NO 2, JALAN 51A/223 PETALING JAYA 46100 SELANGOR 6019-3220792 zam.zarina@philips.com |
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| 2 | 2025-06-11 | AZURION 5 | MDA/FCA/P1320-13417835-2025 | GC10785320-48186 | PHILIPS MALAYSIA SDN BERHAD LEVEL 9, MENARA AXIS, NO 2, JALAN 51A/223 PETALING JAYA 46100 SELANGOR 6019-3220792 zam.zarina@philips.com |
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| 3 | 2025-06-11 | AZURION 7 | MDA/FCA/P1321-82432683-2025 | GC82521235717 | PHILIPS MALAYSIA SDN BERHAD LEVEL 9, MENARA AXIS, NO 2, JALAN 51A/223 PETALING JAYA 46100 SELANGOR 6019-3220792 zam.zarina@philips.com |
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| 4 | 2025-06-11 | AZURION BIPLANE | MDA/FCA/P1322-27795446-2025 | GC59959884718 | PHILIPS MALAYSIA SDN BERHAD LEVEL 9, MENARA AXIS, NO 2, JALAN 51A/223 PETALING JAYA 46100 SELANGOR 6019-3220792 zam.zarina@philips.com |
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| 5 | 2025-06-10 | ADVIA 2120I HEMATOLOGY SYSTEM | MDA/FCA/P1319-85603243-2025 | IVDB3655169817 | SIEMENS HEALTHCARE SDN. BHD. BLOCK A, LEVEL 33A, MENARA THE MET, NO. 20 JALAN DUTAMAS 2, 50480 KUALA LUMPUR, MALAYSIA 50480 WILAYAH PERSEKUTUAN KUALA LUMPUR 6012-2826902 yenli.lam@siemens-healthineers.com |
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| 6 | 2025-06-09 | SPECTRAL CT | MDA/FCA/P1315-33995668-2025 | GC6307722-96412 | PHILIPS MALAYSIA SDN BERHAD LEVEL 9, MENARA AXIS, NO 2, JALAN 51A/223 PETALING JAYA 46100 SELANGOR 6019-3220792 zam.zarina@philips.com |
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| 7 | 2025-06-03 | ROTEM® SIGMA | MDA/FCA/P1301-65308058-2025 | IVDC10235825-198676 | STRAITS SCIENTIFIC (M) SDN BHD NO.10, JALAN NIRWANA 37, TAMAN NIRWANA 68000 SELANGOR 603-92847170 straits@3s.com.my |
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| 8 | 2025-05-30 | VERSANA PREMIER | MDA/FCA/P1307-30709959-2025 | GB7288021-69456 | GE HEALTHCARE SDN. BHD SUITE 1A-1, LEVEL 1 BLOCK 1A,, PLAZA SENTRAL JALAN STESEN SENTRAL 5, KUALA LUMPUR SENTRAL 50470, KUALA LUMPUR MALAYSIA 50470 KUALA LUMPUR 603-22671888 premarket.my@ge.com |
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| 9 | 2025-05-13 | INGENIA AMBITION | MDA/FCA/P1295-67148641-2025 | GB2356219-30045 | PHILIPS MALAYSIA SDN BERHAD LEVEL 9, MENARA AXIS, NO 2, JALAN 51A/223 PETALING JAYA 46100 SELANGOR 6019-3220792 zam.zarina@philips.com |
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| 10 | 2025-04-29 | CREATININE | MDA/FCA/P1275-15944645-2025 | IVDB9994822-104696 | BECKMAN COULTER MALAYSIA SDN. BHD. NO. 18, JALAN TANDANG 51/205A, SEKSYEN 51 46050 SELANGOR 603-77728256 nbintiabdaziz@beckman.com |
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