| No | Date received | Affected Medical Device | MDA Reference No. | MDA Registration No. | Local Establishment Contact Detail | Copy of FSN |
|---|---|---|---|---|---|---|
| 1 | 2024-09-18 | DXH 500 SYSTEM | MDA/FCA/P0990-44347536-2024 | IVDB95852125818 | BECKMAN COULTER MALAYSIA SDN. BHD. NO. 18, JALAN TANDANG 51/205A, SEKSYEN 51 46050 SELANGOR 603-77728256 nbintiabdaziz@beckman.com |
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| 2 | 2024-08-26 | AZURION 5 | MDA/FCA/P0957-17492430-2024 | 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 | 2024-08-23 | STEALTHSTATION S8 CRANIAL SYSTEM | MDA/FCA/P0950-37592428-2024 | GC7686023-140750 | MEDTRONIC MALAYSIA SDN BHD B-23-1, LEVEL 23, THE ASCENT, PARADIGM, NO 1 JALAN SS7/26A, KELANA JAYA 47301 SELANGOR 603-78838000 dl.myreg@medtronic.com |
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| 4 | 2024-08-23 | STEALTHSTATION S8 SPINAL SYSTEM | MDA/FCA/P0951-94529209-2024 | GC6531123-143275 | MEDTRONIC MALAYSIA SDN BHD B-23-1, LEVEL 23, THE ASCENT, PARADIGM, NO 1 JALAN SS7/26A, KELANA JAYA 47301 SELANGOR 603-78838000 dl.myreg@medtronic.com |
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| 5 | 2024-08-23 | STEALTHSTATION S8 ENT SYSTEM | MDA/FCA/P0952-41767684-2024 | GC771281137418 | MEDTRONIC MALAYSIA SDN BHD B-23-1, LEVEL 23, THE ASCENT, PARADIGM, NO 1 JALAN SS7/26A, KELANA JAYA 47301 SELANGOR 603-78838000 dl.myreg@medtronic.com |
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| 6 | 2024-08-23 | STEALTHSTATION FLEXENT SYSTEM | MDA/FCA/P0953-73897794-2024 | GC6421521-58428 | MEDTRONIC MALAYSIA SDN BHD B-23-1, LEVEL 23, THE ASCENT, PARADIGM, NO 1 JALAN SS7/26A, KELANA JAYA 47301 SELANGOR 603-78838000 dl.myreg@medtronic.com |
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| 7 | 2024-08-19 | AZURION 7 | MDA/FCA/P0940-70033550-2024 | 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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| 8 | 2024-08-19 | ATELLICA® CH MICROALBUMIN_2 (MALB_2) | MDA/FCA/P0944-29580606-2024 | IVDB2257286017 | 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 603-79524318 yenli.lam@siemens-healthineers.com |
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| 9 | 2024-08-16 | CENTRICITY PACS (RA1000) | MDA/FCA/P0938-37449326-2024 | GB5191623-131514 | 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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| 10 | 2024-08-08 | AISYS CS2 | MDA/FCA/P0929-57253413-2024 | GC59982267817 | 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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