Field Safety Notices
Field Safety Notice - Jul 2019
31 July 2019
Audiences
Healthcare professional
Industry member
Product-type
Medical devices
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Table caption
Date of Notification | Title | FSN |
|---|---|---|
31 July 2019 | BD Kiestra InoqulA / InoqulA+, Becton, Dickinson and Company (HSA 600:41/01-003/19/09_78) | HSA 6004101-003-19-09_78 FSN [PDF, 8323 KB] (opens in new tab) |
31 July 2019 | BD Alaris Pump Module, CareFusion (HSA 600:41/01-003/19/10_85) Local Contact: Becton Dickinson Holdings Pte. Ltd. | HSA 6004101-003-19-10_85 FSN [PDF, 1508 KB] (opens in new tab) |
31 July 2019 | ZOLL Pro-padz Liquid Gel Radiolucent, ZOLL Medical Corporation (HSA 600:41/01-256/19/02_77) | HSA 6004101-256-19-02_77 FSN [PDF, 224 KB] (opens in new tab) |
31 July 2019 | Atellica® CH 930 Analyzer, Siemens Healthcare Diagnostic Inc. (HSA 600:41/01-022/19/18_75) | HSA 6004101-022-19-18_75 FSN [PDF, 140 KB] (opens in new tab) |
31 July 2019 | Remel™ Salmonella paratyphi B-H phase 1 Flagellar antigen b Stained Suspension, Remel Europe Ltd | HSA 6004101-178-19-03_61 FSN [PDF, 144 KB] (opens in new tab) |
31 July 2019 | Biocell textured breast implants and Biocell textured tissue expanders, Allergan Ltd (HSA 600:41/01-147/19/01_38) | HSA 6004101-147-19-01_38 FSN [PDF, 2912 KB] (opens in new tab) |
31 July 2019 | Rotem ex-tem, Tem Innovations GmbH (HSA 600:41/01-118/19/01_73) | HSA 6004101-118-19-01_73 FSN [PDF, 2456 KB] (opens in new tab) |
30 July 2019 | Patient table of Artis Zee and Artis Q Systems, Siemens Healthcare GmbH (HSA 600:41/01-022/19/17_86) | HSA 6004101-022-19-17_86 FSN [PDF, 722 KB] (opens in new tab) |
29 July 2019 | Reusable Surgical Panetti and Acoustic Neurinoma Instruments, SPIGGLE & THEIS Medizintechnik GmbH (HSA 600:41/01-104/19/02_80) | HSA 6004101-104-19-02_80 FSN [PDF, 1296 KB] (opens in new tab) |
29 July 2019 | Xhale Assurance Nasal Alar SpO2 Sensor, Xhale Assurance, Inc. (HSA 600:41/01-026/19/25_43) | HSA 6004101-026-19-25_43 FSN [PDF, 131 KB] (opens in new tab) |
26 July 2019 | cobas t 711 coagulation analyzer and Cuvette COBAS INTEGRA, Roche Diagnostics GmbH (HSA 600:41/01-016/19/15_31) | HSA 6004101-016-19-15_31 FSN [PDF, 426 KB] (opens in new tab) |
26 July 2019 | QIAsymphony SP, QIAGEN GmbH (HSA 600:41/01-179/19/01_59) Local Contact: QIAGEN Singapore Pte Ltd | HSA 6004101-179-19-01_59 FSN [PDF, 438 KB] (opens in new tab) |
26 July 2019 | Aespire/Aestiva Anesthesia System, Datex-Ohmeda (HSA 600:41/01-010/19/21_50) | HSA 6004101-010-19-21_50 FSN [PDF, 139 KB] (opens in new tab) |
26 July 2019 | BD MAX™ Reagents, Becton Dickinson and Company (HSA 600:41/01-003/19/08_73) | HSA 6004101-003-19-08_73 FSN [PDF, 194 KB] (opens in new tab) |
25 July 2019 | ADIVA Centaur Homocysteine Assay [Folate (100 Test Kit), Folate (500 Test Kit], Siemens Healthcare Diagnostics Inc (HSA 600:41/01-022/19/16_67) | HSA 6004101-022-19-16_67 FSN [PDF, 182 KB] (opens in new tab) |
25 July 2019 | NobelActive Internal NP 3.5x15mm, Nobel Biocare AB (HSA 600:41/01-168/19/02_35) | HSA 6004101-168-19-02_35 FSN [PDF, 74 KB] (opens in new tab) |
25 July 2019 | Portico Solo™ Re-Collapsible Access System, Onset Medical Corporation (HSA 600:41/01-339/19/03_66) | HSA 6004101-339-19-03_66 FSN [PDF, 162 KB] (opens in new tab) |
24 July 2019 | Mammomat Revelation VC10 with Biopsy Option, Siemens Healthcare GmbH (HSA 600:41/01-022/19/15_71) | HSA 6004101-022-19-15_71 FSN [PDF, 1707 KB] (opens in new tab) |
24 July 2019 | High pressure solenoid valve (cobas 8000 modular analyzer series [cobas 8000 ISE module, cobas c 701 module, cobas c 702 module, cobas c 502 module, cobas e 602 module, cobas e 801 module, cobas e 801 analytical unit], cobas 6000 analyzer series [cobas c 501 module, cobas e 601 module], cobas pro integrated solutions [cobas pro ISE analytical unit, cobas c 503 analytical unit], cobas c 513 analyzer and cobas c 311 analyzer), Roche Diagnostic GmbH (HSA 600:41/01-016/19/14_69) | HSA 6004101-016-19-14_69 FSN [PDF, 245 KB] (opens in new tab) |
24 July 2019 | Double Swivel Elbow 15M- Double Flip Top Cap with Seal 22M/15F, and Superset Double Swivel Catheter Mount 22F-Double Flip Top Cap 22M/15F, 70-150mm, Intersurgical Ltd (HSA 600:41/01-209/19/01_76) Local Contact: T.E. Medicare Pte Ltd | HSA 6004101-209-19-01_76 FSN [PDF, 507 KB] (opens in new tab) |
23 July 2019 | Spectra Optia Apheresis System, Terumo BCT Inc HSA 600:41/01-155/19/02_37) | HSA 6004101-155-19-02_37 FSN [PDF, 185 KB] (opens in new tab) |
19 July 2019 | BD 18Gx1-1/2IN Thin Wall (TW) Precision Glide Needles, Becton Dickinson Medical (S) Pte Ltd (HSA 600:41/01-003/19/07_64) | HSA 6004101-003-19-07_64 FSN [PDF, 140 KB] (opens in new tab) |
18 July 2019 | Philips Heartstart MRx Defibrillator/Monitor, Philips Medical Systems (HSA 600:41/01-026/19/24_71) | HSA 6004101-026-19-24_71 FSN [PDF, 648 KB] (opens in new tab) |
18 July 2019 | ORTHO VISION® Analyser for ORTHO BioVue® Cassettes & ORTHO VISION® Max Analyser for ORTHO BioVue® Cassettes, Ortho-Clinical Diagnostic (HSA 600:41/01-303/19/05_61) | HSA 6004101-303-19-05_61 FSN [PDF, 156 KB] (opens in new tab) |
18 July 2019 | Rusch Imex Gold 2 WAY 5 cc -Rubber Valve and Rusch Gold 2WAY 5 cc Plastic Valve, Teleflex Medical Private Limited (HSA 600:41/01-139/19/03_37) | HSA 6004101-139-19-03_37 FSN [PDF, 196 KB] (opens in new tab) |
18 July 2019 | BIB / Orbera Intragastric Balloon Systems, Apollo Endosurgery, Inc. (HSA 600:41/01-263/19/03_35) | HSA 60041-01-263-19-03_35 FSN [PDF, 207 KB] (opens in new tab) |
16 July 2019 | deltastream DP3 3/8" pump head, MEDOS Medizintechnik AG (HSA 600:41/01-112/19/01_56) | HSA 6004101-112-19-01_56 FSN [PDF, 413 KB] (opens in new tab) |
15 July 2019 | Elecsys Anti-CCP, Roche Diagnostics GmbH (HSA 600:41/01-016/19/13_78) | HSA 6004101-016-19-13_78 FSN [PDF, 112 KB] (opens in new tab) |
15 July 2019 | Nurse Control Panel Arm (Long), KeyMed (Medical & Industrial Equipment) Ltd (HSA 600:41/01-004/19/04_66) | HSA 6004101-004-19-04_66 FSN [PDF, 1749 KB] (opens in new tab) |
15 July 2019 | RIC5-9-D and RIC5-9A-RS, GE Healthcare Austria GmbH & Co OG (HSA 600:41/01-010/19/20_79) | HSA 6004101-010-19-20_79 FSN [PDF, 112 KB] (opens in new tab) |
15 July 2019 | Ellipse Implantable Cardioverter Defibrillators (ICDs), St. Jude Medical (HSA 600:41/01-339/19/02_74) | HSA 6004101-339-19-02_74 FSN [PDF, 33 KB] (opens in new tab) |
15 July 2019 | Cobas t711 Coagulation Analyzer, Roche Diagnostic GmbH (HSA 600:41/01-016/19/12_73) | HSA 6004101-016-19-12_73 FSN [PDF, 453 KB] (opens in new tab) |
12 July 2019 | Pressure Transmitter, Getinge Sterilization AB (HSA 600:41/01-224/19/09_62) | HSA 6004101-224-19-09_62 FSN [PDF, 1930 KB] (opens in new tab) |
12 July 2019 | Individual GRIPPER® Needles and PORT-A-CATH® Trays Containing GRIPPER® Needles, Smiths Medical ASD, Inc. (HSA 600:41/01-017/19/02_48) Local Contact: IDS Medical Systems (Singapore) Pte Ltd | HSA 60041-01-017-19-02_48 FSN [PDF, 61 KB] (opens in new tab) |
12 July 2019 | Multigent Lithium and Alinity c Lithium Reagent Kit, Sentinel Diagnostic (HSA 600:41/01-005/19/27_70) | HSA 6004101-005-19-27_70 FSN [PDF, 931 KB] (opens in new tab) |
12 July 2019 | PR4100 Magellan Software Version 7.0 (Code 94195), Bio-Rad Laboratories Inc. (HSA 600:41/01-027/19/05_75) | HSA 6004101-027-19-05_75 FSN [PDF, 152 KB] (opens in new tab) |
12 July 2019 | Comprehensive Reverse Shoulder Instrument Case – Outer (Outer Case Vault Only) & Total (Outer Case Vault Only), Biomet Orthopedics (HSA 600:41/01-008/19/05_50) | HSA 6004101-008-19-05_50 FSN [PDF, 311 KB] (opens in new tab) |
11 July 2019 | Brilliance iCT, Brilliance 64, Ingenuity Core, Ingenuity Core 128, Philips Medical Systems (Cleveland), Inc (HSA 600:41/01-026/19/23_86) | HSA 6004101-026-19-23_86 FSN [PDF, 495 KB] (opens in new tab) |
11 July 2019 | Rx Daytona Plus Analyser and RX Imola Analyser, Randox Laboratories Ltd (HSA 600:41/01-213/19/02_34) | HSA 6004101-213-19-02_34 FSN [PDF, 2970 KB] (opens in new tab) |
11 July 2019 | Cook Acuject Variable Injection Needle, Wilson-Cook Medical, Inc. (HSA 600:41/01-013/19/08_80) | HSA 6004101-013-19-08_80 FSN [PDF, 982 KB] (opens in new tab) |
10 July 2019 | Platelia Toxo IgA TMB, Bio-Rad Laboratories (HSA 600:41/01-027/19/04_67) | HSA 6004101-027-19-04_67 FSN [PDF, 154 KB] (opens in new tab) |
10 July 2019 | Immundiagnostik Remsima® Monitor Total ADA ELISA, Immundiagnostik AG (HSA 600:41/01-342/19/01_31) | HSA 6004101-342-19-01_31 FSN [PDF, 260 KB] (opens in new tab) |
8 July 2019 | ICS Chartr EP 200, GN Otometrics A/S (HSA 600:41/01-104/19/01_68) | HSA 6004101-104-19-01_68 FSN [PDF, 7679 KB] (opens in new tab) |
8 July 2019 | Monaco, Elekta, Inc. (HSA 600:41/01-101/19/01_74) | HSA 6004101-101-19-01_74 FSN [PDF, 1195 KB] (opens in new tab) |
8 July 2019 | TechnegasPlus Generator, Cyclomedica Australia Pty Ltd (HSA 600:41/01-087/19/03_52) | HSA 6004101-087-19-03_52 FSN [PDF, 5777 KB] (opens in new tab) |
5 July 2019 | Philips Azurion Interventional Fluoroscopic X-ray system, with software version 1.2, Philips Medical Systems Nederland B.V. (HSA 600:41/01-026/19/21_43) | HSA 6004101-026-19-21_43 FSN [PDF, 171 KB] (opens in new tab) |
4 July 2019 | Covidien Emprint™ Ablation Systems (Emprint™ Ablation Generator, Ablation Reusable Cable, Ablation Pump, RF Ablation Footswitch, Remote Temparature Probe), Covidien llc (HSA 600:41/01-046/19/08_64) | HSA 6004101-046-19-08_64 FSN [PDF, 192 KB] (opens in new tab) |
4 July 2019 | AXIUS Blower Mister, Maquet Cardiovascular, LLC (HSA 600:41/01-224/19/08_63) | HSA 6004101-224-19-08_63 FSN [PDF, 96 KB] (opens in new tab) |
3 July 2019 | LANTIS Oncology Information System Server, Siemens Healthcare GmbH (HSA 600:41/01-022/19/14_86) | HSA 6004101-022-19-14_86 FSN [PDF, 50 KB] (opens in new tab) |
3 July 2019 | MAC™ VU360 System, GE Medical Systems Information Technologies, Inc. (HSA 600:41/01-010/19/19_51) | HSA 6004101-010-19-19_51 FSN [PDF, 196 KB] (opens in new tab) |
11 Jun 2019 | BrightView SPECT, BrightView X, BrightView XCT Handcontroller, Philips Medical Systems (Cleveland), Inc. (HSA 600:41/01-026/19/17_38) | HSA 6004101-026-19-17_38 FSN [PDF, 491 KB] (opens in new tab) This FSN is an update to the original FSN published in June 2019. |
27 May 2019 | HeartStart MRx Defibrillator/ Monitor, Philips Medical Systems (HSA 600:41/01-026/19/15_68) | HSA 6004101-026-19-15_68 FSN [PDF, 455 KB] (opens in new tab) This FSN is an update to the original FSN published in May 2019. |
11 Apr 2019 | Dornier Standard Diode and Nd:YAG Lightguides, Dornier MedTech GmbH (HSA 600:41/01-161/19/01_38) | HSA 6004101-161-19-01_38 FSN [PDF, 1108 KB] (opens in new tab) This FSN is an update to the original FSN published in April 2019. |
9 Apr 2019 | Philips IntelliVue MX40, Philips Medical Systems (HSA 600:41/01-026/19/11_48) | HSA 6004101-026-19-11_48 FSN [PDF, 250 KB] (opens in new tab) This FSN is an update to the original FSN published in April 2019. |
23 Mar 2019 | Giraffe Bedded Warmer & Panda iRes Warmer, Datex-Ohmeda Inc (HSA 600:41/01-010/19/07_35) | HSA 6004101-010-19-07_35 FSN [PDF, 2584 KB] (opens in new tab) This FSN is an update to the original FSN published in March 2019. |