| No | Date received | Affected Medical Device | MDA Reference No. | MDA Registration No. | Local Establishment Contact Detail | Copy of FSN |
|---|---|---|---|---|---|---|
| 1 | 2024-11-05 | IMMULITE / IMMULITE 1000 TNF ALPHA | MDA/FCA/P1051-94138530-2024 | IVDB95844112218 | 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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| 2 | 2024-10-24 | PHILIPS VUE PACS | MDA/FCA/P1039-67076394-2024 | GB18651834218 | 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 | 2024-10-22 | TRILOGY EVO | MDA/FCA/P1035-74179596-2024 | GC2627520-39891 | 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 | 2024-10-21 | VISTHESIA 1.5% | MDA/FCA/P1012-59747634-2024 | GD948681330219 | CARL ZEISS SDN BHD AXIS BUSINESS CAMPUS, UNIT G.02, BLOCK B, NO.13 & 13A, JALAN 51A/225, SEKSYEN 51A, 46100 PETALING JAYA, SELANGOR 46100 SELANGOR 603-79326600 siao-yi.won@zeiss.com |
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| 5 | 2024-10-17 | TruSystem 7000 Surgical table, universal | MDA/FCA/P1026-66662818-2024 | GA10975523-128720 | WELCH ALLYN MALAYSIA SDN BHD LOT NO. B-21-3, LEVEL 21, THE ASCENT PARADIGM, NO. 1, JALAN SS7/26A, KELANA JAYA, PETALING JAYA, SELANGOR 47301 SELANGOR 6012-78843341 nukun_sim@baxter.com |
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| 6 | 2024-10-11 | ZENITION 50 | MDA/FCA/P1019-58353164-2024 | GC2933619-31252 | 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 | 2024-10-11 | ZENITION 70 | MDA/FCA/P1020-90809242-2024 | GC2523519-30212 | 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 | 2024-10-10 | UROPASS URETERAL ACCESS SHEATH SET | MDA/FCA/P1016-73629562-2024 | GB32940617118 | OLYMPUS (MALAYSIA) SDN. BHD. UNIT T2-L05-1, PJ33, NO. 3, JALAN PROFESSOR KHOO KAY KIM, SEKSYEN 13 47301 SELANGOR 603-76508990 mes-ra.oml@olympus.com |
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| 9 | 2024-10-10 | CENTRICITY UNIVERSAL VIEWER ZERO FOOTPRINT | MDA/FCA/P1017-22045514-2024 | GB7561822-102555 | 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 | 2024-10-08 | ATELLICA IM ERYTHROPOIETIN (EPO) | MDA/FCA/P1014-93545672-2024 | IVDB5198820-45185 | 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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