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Date of Notification
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Title
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FSN
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| 27 Sep 2019 |
Nasal Alar SpO2 Sensor, Xhale Assurance Inc (HSA 600:41/01-026/19/33_64)
Local Contact: Philips Electronics (Singapore) Pte Ltd
Contact No./Email: 1800 747 5477
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HSA 6004101-026-19-33_64 FSN131 KB |
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27 Sep 2019
|
Carescape B850 monitors of version MBC303, GE Healthcare Finland Oy (HSA 600:41/01-010/19/25_37)
Local Contact: GE Healthcare Pte Ltd
Contact No./Email: 6277 7668 / svc@ge.com
|
HSA 6004101-010-19-25_37 FSN237 KB |
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26 Sep 2019
|
Elekta Mosaiq, Elekta Inc (HSA 600:41/01-101/19/02_79)
Local Contact: Elekta Pte Ltd
Contact No./Email: 6221 2322 / Elekta_Global_PMS@Elekta.com
|
HSA 6004101-101-19-02_79 FSN117 KB |
| 26 Sep 2019 |
Prismaflex M100 and TPE2000 sets, Oxiris set, MARS Treatment Kit type 1116/1 X-MARS, Gambro Lamdia AB (HSA 600:41/01-001/19/03_37)
Local Contact: Baxter Healthcare (Asia) Pte Ltd
Contact No./Email: 6826 2616
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HSA 6004101-001-19-03_37 FSN375 KB |
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24 Sep 2019
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Atellica® CH 930 Analyzer, Siemens Healthcare Diagnostics Inc. (HSA 600:41/01-022/19/24_75)
Local Contact: Siemens Healthcare Pte Ltd
Contact No./Email: ui-handling.sg.dl@siemens-healthineers.com
|
HSA 6004101-022-19-24_75 FSN139 KB |
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24 Sep 2019
|
Implantable Ports & GROSHONG® Central Venous Catheter, BARD Access Systems Inc. (HSA 600:41/01-050/19/04_64)
Local Contact: BARD SINGAPORE PTE LTD
Contact No./Email: 6664 2784 / Complaints.Singapore@bd.com
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HSA 6004101-050-19-04_64 FSN605 KB |
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23 Sep 2019
|
HCYS (Homocysteine Enzymatic Assay), Roche Diagnostics GmbH (HSA 600:41/01-016/19/21_67)
Local Contact: Roche Diagnostics Asia Pacific Pte Ltd
Contact No./Email: sg.regulatory@roche.com
|
HSA 6004101-016-19-21_67 FSN25 KB |
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23 Sep 2019
|
DC-Screening II, DiaMed GmbH (HSA 600:41/01-027/19/09_49)
Local Contact: Bio-Rad Laboratories (Singapore) Pte Ltd
Contact No./Email: 6490 4262
|
HSA 6004101-027-19-09_49 FSN1811 KB |
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23 Sep 2019
|
Olympus DuodenoVideoscope, Olympus DuodenoFiberscope, Olympus Medical Systems Corp. (HSA 600:41/01-004/19/05_48)
Local Contact: Olympus Singapore Pte Ltd
Contact No./Email: mes-ra.osp@olympus-ap.com
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HSA 6004101-004-19-05_48 FSN254 KB |
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23 Sep 2019
|
ThermoScientific Oxoid Violet Red Bile Glucose Agar (ISO), Oxoid Limited (HSA 600:41/01-178/19/06_57)
Local Contact: Thermo Scientific Microbiology Pte Ltd
Contact No./Email: 6499 9999 / cs.mbd.sg@thermofisher.com
|
HSA 6004101-178-19-06_57 FSN229 KB |
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20 Sep 2019
|
Philips V60 Ventilators, Respironics California LLC (HSA 600:41/01-026/19/31_51)
Local Contact: Philips Electronics (Singapore) Pte Ltd
Contact No./Email: 1800 744 5477
|
HSA 6004101-026-19-31_51 FSN492 KB |
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20 Sep 2019
|
PHILIPS V60/V680 VENTILATOR Touchscreen RP Kit, Respironics California LLC (HSA 600:41/01-026/19/32_44)
Local Contact: Philips Electronics (Singapore) Pte Ltd
Contact No./Email: 1800 744 5477
|
HSA 6004101-026-19-32_44 FSN410 KB |
| 20 Sep 2019 |
O-Wrap, Tissue-Vault, and CryoStore Accessories, ORIGEN BIOMEDICAL INC. (HSA 600:41/01-348/19/01_35)
Local Contact: Essential Resource Marketing
Contact No./Email: ermspore@singnet.com.sg
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HSA 6004101-348-19-01_35 FSN119 KB |
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20 Sep 2019
|
Philips V680 Ventilator, Respironics California LLC (HSA 600:41/01-026/19/30_77)
Local Contact: Philips Electronics (Singapore) Pte Ltd
Contact No./Email: 1800 744 5477
|
HSA 6004101-026-19-30_77 FSN423 KB |
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20 Sep 2019
|
iLab™ Polaris Systems (Polaris 2.10), Boston Scientific Corporation (HSA 600:41/01-007/19/08_35)
Local Contact: Boston Scientific Asia Pacific Pte Ltd
Contact No./Email: 6418 8888
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HSA 6004101-007-19-08_35 FSN172 KB |
|
19 Sep 2019
|
Alinity i Processing Module; Alinity c Processing Module; Alinity ci Level Sensor, Abbott GmbH & Co KG (HSA 600:41/01-005/19/29_31)
Local Contact: Abbott Laboratories Singapore Pte Ltd
Contact No./Email: 6914 8000 / FSN_enquiry@abbott.com
|
HSA 6004101-005-19-29_31 FSN762 KB |
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19 Sep 2019
|
EV1000 Clinical Platform NI, Edwards Lifesciences LLC (HSA 600:41/01-060/19/06_66)
Local Contact: Edwards Lifesciences (Asia) Pte Ltd
Contact No./Email: 6548 5923
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HSA 6004101-060-19-06_66 FSN203 KB |
| 17 Sep 2019 |
KIT CONSTITUENT SUBSTRATE BUFFER (SUB-D) of four GenoType Mycobacterium Kits (GenoType MTBDRplus, GenoType Mycobacterium CM, GenoType MTBDRsl, GenoType Mycobacterium AS), Hain Lifescience (HSA 600:41/01-086/19/01_57)
Local Contact: SPD Scientific Pte Ltd
Contact No./Email: 6303 9837 / sales.sg@spdscientific.com
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HSA 6004101-086-19-01_57 FSN1151 KB |
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17 Sep 2019
|
Respironics V60 Ventilator, RespironIcs California LLC (HSA 600:41/01-026/19/29_66)
Local Contact: Philips Electronics (Singapore) Pte Ltd
Contact No./Email: 1800 744 5477
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HSA 6004101-026-19-29_66 FSN2246 KB |
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17 Sep 2019
|
GE ApexPro Telemetry System, GE Medical Systems Information Technologies, Inc (HSA 600:41/01-010/19/24_38)
Local Contact: GE Healthcare Pte Ltd
Contact No./Email: 6277 7668 / svc@ge.com
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HSA 6004101-010-19-24_38 FSN263 KB |
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17 Sep 2019
|
Heater Unit HU 35, Maquet Cardiopulmonary GmbH (HSA 600:41/01-224/19/12_37)
Local Contact: Getinge South East Asia Pte Ltd
Contact No./Email: 6296 1992
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HSA 6004101-224-19-12_37 FSN563 KB |
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16 Sep 2019
|
Virotrol HIV-2 Control, Bio-Rad Laboratories (HSA 600:41/01-027/19/08_31)
Local Contact: Bio-Rad Laboratories (Singapore) Pte Ltd
Contact No./Email: 6490 4262
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HSA 6004101-027-19-08_31 FSN46 KB |
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16 Sep 2019
|
BD Emerald™ Syringe, Becton Dickinson India (P) Ltd(HSA 600:41/01-003/19/13_38)
Local Contact: Becton Dickinson Holdings Pte Ltd
Contact No./Email: 6664 2784 / customercomplaint@bd.com
|
HSA 6004101-003-19-13_38 FSN63 KB |
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13 Sep 2019
|
Venous Hardshell Cardiotomy Reservoir (VHK 70000/71000) and combination of reservoir with oxygenator (VKMO, VKMOD), Maquet Cardiopulmonary GmbH (HSA 600:41/01-224/19/10_71)
Local Contact: Getinge South East Asia Pte Ltd
Contact No./Email: 6296 1992
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HSA 6004101-224-19-10_71 FSN3513 KB |
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13 Sep 2019
|
Disposable CO2 Absorbers, Maquet Critical Care AB (HSA 600:41/01-224/19/11_48)
Local Contact: Getinge South East Asia Pte Ltd
Contact No./Email: 6296 1992 ext 118
|
HSA 6004101-224-19-11_48 FSN1933 KB |
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13 Sep 2019
|
Various Legacy Biomet Products, Biomet Orthopedics (HSA 600:41/01-008/19/07_18)
Local Contact: Zimmer Pte Ltd
Contact No./Email: 6854 7222 / MG-PAC-SG-RegulatoryContact@zimmerbiomet.com
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HSA 6004101-008-19-07_18 FSN770 KB |
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12 Sep 2019
|
Atellica IM anti-CCP IgG (aCCP) Assay, Atellica IM Pregnancy-Associated Plasma Protein-A (PAPP-A) Assay, Siemens Healthcare Diagnostics Inc. (HSA 600:41/01-022/19/23_69)
Local Contact: Siemens Healthcare Pte Ltd
Contact No./Email: ui-handling.sg.dl@siemens-healthineers.com
|
HSA 6004101-022-19-23_69 FSN190 KB |
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12 Sep 2019
|
Alinity hq Analyser and Alinity hs Slide Marker Stainer Module, Abbott GmbH & Co. Kg (HSA 600:41/01-005/19/28_59)
Local Contact: Abbott Laboratories Singapore Pte. Ltd.
Contact No./Email: 6914 8000 / FSN_enquiry@abbott.com
|
HSA 6004101-005-19-28_59 FSN272 KB |
|
11 Sep 2019
|
Ortho-Clinical VITROS Chemistry Products Cl- (Chloride) & K+ Slides (Potassium), Ortho-Clinical Diagnostic (HSA 600:41/01-303/19/07_34)
Local Contact: Ortho-Clinical Diagnostics Singapore Pte Ltd
Contact No./Email: 6486 1151
|
HSA 6004101-303-19-07_34 FSN163 KB |
|
11 Sep 2019
|
MESA Rail Cutter, K2M, Inc. (HSA 600:41/01-322/19/01_56)
Local Contact: Asia Actual Pte Ltd
Contact No./Email: 6348 0481
|
HSA 6004101-322-19-01_56 FSN192 KB |
|
9 Sep 2019
|
1-DAY ACUVUE® MOIST® for ASTIGMATISM Brand Contact Lenses, Johnson & Johnson Vision Inc. (HSA 600:41/01-140/19/01_74)
Local Contact: Johnson & Johnson Vision Care
Contact No./Email: 6918 7295
|
HSA 6004101-140-19-01_74 FSN518 KB |
|
6 Sep 2019
|
DiaMed IH-1000, DiaMed GmbH (HSA 600:41/01-027/19/07_23)
Local Contact: Bio-Rad Laboratories (Singapore) Pte Ltd
Contact No./Email: 6490 4262
|
HSA 6004101-027-19-07_23 FSN5373 KB |
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6 Sep 2019
|
Achilles Express and Achilles Insights Systems, GE Medical Systems Ultrasound & Primary Care Diagnostic, LLC (HSA 600:41/01-010/19/23_52)
Local Contact: GE Healthcare Pte Ltd
Contact No./Email: 6277 7668 / svc@ge.com
|
HSA 6004101-010-19-23_52 FSN314 KB |
|
4 Sep 2019
|
STRATAFIX™ Spiral PDS Plus Knotless Tissue Control Device, Ethicon, LLC (HSA 600:41/01-002/19/15_51)
Local Contact: Johnson & Johnson Pte Ltd
Contact No./Email: 6918 6717
|
HSA 6004101-002-19-15_51 FSN315 KB |
| 4 Sep 2019 |
Euphora™ Semi-Compliant Rapid Exchange Balloon Dilatation Catheters, Medtronic Inc (HSA 600:41/01-009/19/12_56)
Local Contact: Medtronic International Limited
Contact No./Email: 6436 5077
|
HSA 6004101-009-19-12_56 FSN159 KB |
|
4 Sep 2019
|
Philips Access Computed Tomography X-ray system, Philips Healthcare (Suzhou) CO. Ltd (HSA 600:41/01-026/19/28_79)
Local Contact: Philips Electronic (Singapore) Pte Ltd
Contact No./Email: 1800 744 5477
|
HSA 6004101-026-19-28_79 FSN9962 KB |
|
3 Sep 2019
|
Convex Two-Piece Skin Barriers i.e. Natura / Surfit / Combihesive Wafers, ConvaTec Limited (HSA 600:41/01-347/19/01_87)
Local Contact: ConvaTec (Singapore) Pte Ltd
Contact No./Email: 6245 9838
|
HSA 6004101-347-19-01_87 FSN939 KB |
| 3 Sep 2019 |
Introcan Safety Pur 24G, 0.7X19MM-AP, B.Braun Melsungen AG (HSA 600:41/01-012/19/04_85)
Local Contact: B. Braun Singapore Pte Ltd
Contact No./Email: 6213 0933 / bbraun.sg@bbraun.com
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HSA 6004101-012-19-04_85_FSN2826 KB |
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2 Sep 2019
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Triathlon Total Knee Replacement System, Howmedica Osteonics Corporation (HSA 600:41/01-014/19/04_74)
Local Contact: Stryker Singapore Pte. Ltd
Contact No./Email: 6662 5930
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HSA 6004101-014-19-04_74 FSN151 KB |
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2 Sep 2019
|
ALB2 (Albumin Gen.2) and BILT3 (Bilirubin Total Gen.3), Roche Diagnostics GmbH (HSA 600:41/01-016/19/19_61)
Local Contact: Roche Diagnostics Asia Pacific Pte Ltd
Contact No./Email: sg.regulatory@roche.com
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HSA 6004101-016-19-19_61 FSN401 KB |
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2 Sep 2019
|
IgG-2 Tina-quant IgG Gen.2, Roche Diagnostics GmbH (HSA 600:41/01-016/19/20_61)
Local Contact: Roche Diagnostics Asia Pacific Pte Ltd
Contact No./Email: sg.regulatory@roche.com
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HSA 6004101-016-19-20_61 FSN20 KB |
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26 July 2019
|
BD MAX™ Reagents, Becton Dickinson and Company (HSA 600:41/01-003/19/08_73)
Local Contact: Becton Dickinson Holdings Pte Ltd
Contact No./Email: 6664 2784
|
HSA 6004101-003-19-08_73 FSN205 KB
This FSN is an update to the original FSN published in July 2019.
|
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8 July 2019
|
ICS Chartr EP 200, GN Otometrics A/S (HSA 600:41/01-104/19/01_68)
Local Contact: SurgiPro Pte Ltd
Contact No./Email: 6894 6038 / sales@surgipro.com.sg
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HSA 6004101-104-19-01_68 FSN201 KB
This FSN is an update to the original FSN published in July 2019.
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