Інформація, отримана з іноземних систем повідомлення про продукцію, що становить серйозний ризик, за період 01.03.2020 – 30.04.2020
Опубліковано 01.05.2020 о 13:53https://fsca.swissmedic.ch/mep/#/
29.04.2020 (Updated 01.05.2020) |
Bentley InnoMed GmbH |
BeGraft Coronary Stent Graft System |
MD: Mesh-sleeve coronary artery stent |
Vk_20200422_09 |
|
30.04.2020 |
Siemens Healthcare GmbH; Business Area Advanced Therapies |
Artis icono |
MD: Stationary angiographic x-ray system, digital |
Vk_20200427_05 |
|
30.04.2020 |
GS Elektromedizinische Geräte G. Stemple GmbH |
Battery corpuls cpr |
MD: Secondary battery |
Vk_20200423_08 |
|
30.04.2020 |
Dr. J Hänsler GmbH |
OZONOSAN Germ Stop Transfer Filter Set |
MD: Filters, Bacteria |
Vk_20200422_11 |
|
28.04.2020 (Updated 30.04.2020) |
Medion Grifols Diagnostics AG |
Reverse-Cyte 0.8% A1, A2, B, 0 |
IVD: ABO grouping cell kit |
Vk_20200421_13 |
|
07.04.2020 (Updated 30.04.2020) |
Gambro Lundia AB |
PrisMax Hemodialysis Machine Prismaflex System |
MD: Haemodialysis system, institutional MD: Haemodialysis system, institutional |
Vk_20200402_13 |
|
29.04.2020 |
DiaSys Diagnostic Systems GmbH |
Creatinine FS Creatinine PAP FS Bilirubin Auto Total FS Bilirubin Auto Direct FS |
IVD: Creatinine kit IVD: Creatinine kit IVD: Bilirubin kit IVD: Substrates |
Vk_20200424_10 |
|
28.04.2020 |
Schiller AG |
medilogAR |
MD: Electrocardiographic ambulatory recorder |
Vk_20200424_08 |
|
28.04.2020 |
Radiometer Medical ApS |
ABL80 FLEX CO-OX |
IVD: Metabolic profile clinical chemistry analyser IVD, portable, automated |
Vk_20200424_02 |
|
23.04.2020 |
Siemens Healthcare GmbH; Business Area Advanced Therapies |
Cios Spin Cios Alpha |
MD: Portable general-purpose fluoroscopic x-ray system, digital MD: Portable general-purpose fluoroscopic x-ray system, digital |
Vk_20200420_07 |
|
27.03.2020 (Updated 23.04.2020) |
Aesculap AG |
Various surgical instruments for use at the central nervous system |
MD: surgical instruments for use at the central nervous system |
Vk_20200311_17 |
|
15.04.2020 (Updated 22.04.2020) |
Radiometer Medical ApS |
AQT90 FLEX Analyzers |
IVD: Fluorescent immunoassay analyser (FIA), stationary |
Vk_20200408_21 |
|
22.04.2020 |
HeartWare Inc. |
HeartWare Ventricular Assist System – HVAD Pump Implant Kit |
AIMD: Artificial heart, temporary |
Vk_20200408_03 |
|
21.04.2020 |
Philips Medical Systems Nederland BV |
Philips Azurion 7 M20 |
MD: Stationary general-purpose fluoroscopic x-ray system, analogue |
Vk_20200417_05 |
|
21.04.2020 |
Organ Assist |
Liverassist |
MD: General-purpose donor-organ preservation/transport system |
Vk_20200416_08 |
|
14.04.2020 (Updated 21.04.2020) |
Siemens Healthcare Diagnostics Products GmbH |
Coagulation Factor V Deficient Plasma |
IVD: Coagulation factor V IVD, reagent |
Vk_20200414_04 |
|
21.04.2020 |
Valoc AG |
Adapter Optiloc for handpiece, length 26mm |
MD: Surgical screwdriver, reusable |
Vk_20200406_16 |
|
17.04.2020 |
Siemens Healthcare Diagnostics Products GmbH |
Dade Actin Activated Cephaloplastin Reagent |
IVD: Activated partial thromboplastin time (APTT) IVD, reagent |
Vk_20200414_05 |
|
16.04.2020 |
Elitech Clinical Systems SAS |
ELITech RHEUMATOID FACTOR |
IVD: Rheumatoid factor IVD, kit, nephelometry/turbidimetry |
Vk_20200414_03 |
|
16.04.2020 |
Ivoclar Vivadent AG |
IPS e.max ZirCAD CER/inLab LT A1-A3 C17/5 |
MD: Dental appliance fabrication material, ceramic |
Vk_20200406_02 |
|
16.04.2020 |
Natus Medical Denmark, GN Otometrics A/S |
Aircal |
MD: Caloric vestibular-stimulation system |
Vk_20200330_01 |
|
15.04.2020 |
Elekta, Inc. |
Monaco RTP System |
MD: Radiation therapy software |
Vk_20200407_09 |
|
31.03.2020 (Updated 15.04.2020) |
GCE s.r.o. |
Combilite Valve |
MD: Valve |
Vk_20200311_18 |
|
14.04.2020 |
Fast-Track Diagnostics S.a.r.l. |
FTD Vesicular rash |
IVD: Multiple meningitis-associated microorganism nucleic acid IVD, kit, nucleic acid technique (NAT) |
Vk_20200414_01 |
|
14.04.2020 |
Spectranetics Corporation |
Bridge Occlusion Balloon |
MD: Intravascular occluding balloon catheter, image-guided |
Vk_20200409_23 |
|
14.04.2020 |
Qiagen GmbH |
therascreen EGFR RGQ PCR Kit (24) therascreen EGFR Plasma RGQ PCR Kit (24) |
IVD: Other Acquired Gene or Chromosome Alteration Tests IVD: Other Acquired Gene or Chromosome Alteration Tests |
Vk_20200408_15 |
|
11.03.2020 (Updated 14.04.2020) |
RaySearch Laboratories AB |
RayStation |
MD: Radiation therapy software |
Vk_20200304_14 |
|
13.04.2020 |
Inpeco S.A. |
Aptio Automation |
IVD: Specimen processing instrument IVD, automated |
Vk_20200324_03 |
|
25.03.2020 (Updated 13.04.2020) |
Inpeco S.A. |
ACCELERATOR a3600 |
IVD: Specimen processing instrument IVD, automated |
Vk_20200324_02 |
|
25.03.2020 (Updated 13.04.2020) |
Inpeco S.A. |
FlexLab |
IVD: Specimen processing instrument IVD, automated |
Vk_20200324_01 |
|
09.04.2020 |
Beckman Coulter Ireland, Inc. |
iChemVELOCITY Automated Urine Chemistry System iQ200 Series Urine Microscopy Analyzer |
IVD: Urine analyser IVD, laboratory, automated IVD: Urine analyser IVD, laboratory, automated |
Vk_20200407_01 |
|
09.04.2020 |
Biomet Orthopedics |
Comprehensive |
MD: Orthopaedic implant inserter/extractor, reusable |
Vk_20200402_11 |
|
07.04.2020 |
Synaptive Medical Inc |
ClearCanvas RIS/PACS |
MD: Radiology PACS software |
Vk_20200327_02 |
|
07.04.2020 |
LeMaitre Vascular, Inc. |
LeMaitre Over-the-Wire Embolectomy Catheters |
MD: Thrombectomy balloon catheter |
Vk_20200325_04 |
|
07.04.2020 |
Smith & Nephew, Inc. |
Footprint Ultra PK Suture Anchor |
MD: Ligament bone anchor |
Vk_20200325_03 |
|
26.03.2020 (Updated 06.04.2020) |
EUROIMMUN Medizinische Labordiagnostika AG |
Anti-Zika-Virus-ELISA (IgG) |
IVD: Other Viral Antigen/Antibody Detection |
Vk_20200318_08 |
|
05.02.2020 (Updated 06.04.2020) |
Siemens Healthcare Diagnostics Inc. |
Atellica CH 930 Reaction Cuvette Segment |
IVD: Laboratory analyser cuvette IVD, reusable |
Vk_20200128_08 |
|
31.03.2020 (Updated 02.04.2020) |
Smiths Medical ASD, Inc. |
CADD-Solis Ambulatory Infusion Pump |
MD: General-purpose infusion pump, line-powered |
Vk_20200325_01 |
|
20.03.2020 (Updated 02.04.2020) |
Welch Allyn Inc |
Cable Leads S4, T12, X12+ ELI devices, RScribe, ELI PC H12+ S12/S19 Q-Stress Xscribe |
MD: Electrocardiographic lead set, reusable MD: Electrocardiography telemetric monitoring system transmitter MD: Electrocardiograph, professional, multichannel MD: Electrocardiographic ambulatory recorder MD: Multiple-patient intensive/general healthcare physiologic monitoring system MD: Stress exercise monitoring system computer MD: Cardiac stress exercise monitoring system |
Vk_20200316_04 |
|
01.04.2020 |
Philips Medical Systems Nederland BV |
Philips Azurion system |
MD: Stationary general-purpose fluoroscopic x-ray system, analogue |
Vk_20200327_04 |
|
01.04.2020 |
Vascular Solutions Inc. |
Langston Dual Lumen Catheter |
MD: Angiographic catheter, single-use |
Vk_20200326_02 |
|
31.03.2020 |
Boston Scientific Corporation |
GreenLight MoXy Fiber Optic |
MD: Urogenital surgical laser system beam guide, single-use |
Vk_20200331_01 |
|
31.03.2020 |
Merit Medical Systems, Inc. |
PreludeSYNC DISTAL |
MD: Vascular compressor, external |
Vk_20200330_02 |
|
25.03.2020 (Updated 31.03.2020) |
Abbott Diagnostics Technologies AS |
Alere Afinion 2 Afinion 2 Alere Afinion AS100 Analyzer |
IVD: Single-channel clinical chemistry analyser IVD, point-of-care IVD: Single-channel clinical chemistry analyser IVD, point-of-care IVD: Single-channel clinical chemistry analyser IVD, point-of-care |
Vk_20200323_16 |
|
31.03.2020 |
Quality In Flow (QinFlow) Ltd. |
AC power supply module |
MD: Basic power supply |
Vk_20200317_17 |
|
25.03.2020 (Updated 30.03.2020) |
Chromsystems Instruments & Chemicals GmbH |
3PLUS1 Multilevel Plasma Calibrator Set Neuroleptics 1 /EXTENDED MassCheck Neuroleptics 1 /EXTENDED Plasma Control Level 1 MassCheck Neuroleptics 1 /EXTENDED Plasma Control Level II |
IVD: Multiple antipsychotic therapeutic drug monitoring IVD, kit, liquid chromatography/mass spectrometry (LC/MS) IVD: Multiple antipsychotic therapeutic drug monitoring IVD, kit, liquid chromatography/mass spectrometry (LC/MS) IVD: Multiple antipsychotic therapeutic drug monitoring IVD, kit, liquid chromatography/mass spectrometry (LC/MS) |
Vk_20200317_06 |
|
17.03.2020 (Updated 30.03.2020) |
Servona GmbH |
Servona Silberkanüle |
MD: Tenaculum, uterine |
Vk_20200313_08 |
|
19.03.2020 (Updated 30.03.2020) |
Axis-Shield Diagnostics Limited |
Alere NT-proBNP Control Alere NT-pro BNP Calibrator |
IVD: B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, control IVD: B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, calibrator |
Vk_20200313_06 |
|
30.03.2020 |
PETER BREHM GmbH |
Screw M6 short Allen Key SW 5 Ball Head Screw M6 long |
MD: Prostheses, Joint, Hip, Femoral Component MD: Allen Key MD: Prostheses, Joint, Hip, Femoral Component |
Vk_20200221_07 |
|
25.03.2020 |
Philips Medical Systems |
HeartStart MRx Defibrillator/ Monitor |
MD: Rechargeable professional automated external defibrillator |
DE-1-Distributoren |
Vk_20200323_18 |
25.03.2020 |
Embla Systems |
Remlogic |
MD: Sleep disorder interpretive software |
Vk_20200316_05 |
|
24.03.2020 |
Philips Medical Systems |
TRx4841A 1.4 GHz IntelliVue Tele TRX TRx4851A 2.4 GHz IntelliVue Tele TRX |
MD: Monitor, physiological, patient (with arrhythmia detection or alarm) MD: Monitor, physiological, patient (with arrhythmia detection or alarm) |
Vk_20200323_04 |
|
24.03.2020 |
Waldemar Link GmbH & Co. KG |
Endo-Model Knee Fusion Nail, Femoral, left, Size 1 |
MD: Knee arthrodesis prosthesis |
Vk_20200317_03 |
|
24.03.2020 (Updated 24.03.2020) |
Dedienne Santé |
Symbol Cup |
MD: Acetabular shell |
Vk_20200303_06 |
|
19.03.2020 (Updated 23.03.2020) |
Siemens Healthcare Diagnostics Products GmbH |
Dade Ci-Trol 1 |
IVD: Multiple coagulation factor IVD, control |
Vk_20200316_14 |
|
12.11.2019 (Updated 23.03.2020) |
TORNIER SAS |
Aequalis Ascend Flex Shoulder System |
MD: Total reverse shoulder prosthesis |
Vk_20191107_21 |
|
11.03.2020 (Updated 21.03.2020) |
Sysmex Corporation |
UF-4000 UF-5000 |
IVD: INSTRUMENTS , CONSUMABLES, SPARE PARTS, SOFTWARE, SERVICE IVD: INSTRUMENTS , CONSUMABLES, SPARE PARTS, SOFTWARE, SERVICE |
Vk_20200304_05 |
|
04.03.2020 (Updated 21.03.2020) |
Biocartis NV |
Idylla EGFR Mutation Test |
IVD: Epidermal growth factor receptor (EGFR) gene mutation/mRNA expression IVD, kit, nucleic acid technique (NAT) |
Vk_20200225_16 |
|
20.03.2020 |
C-RAD Positioning AB |
c-Rad c4D software |
MD: Radiation therapy software |
Vk_20200302_15 |
|
20.03.2020 |
MAG & more |
PowerMAG |
MD: Stimulator |
Vk_20200203_24 |
|
28.01.2020 (Updated 20.03.2020) |
Roche Diagnostics GmbH |
Elecsys CA 19-9 |
IVD: Cancer antigen 19-9 (CA19-9) IVD, kit, chemiluminescent immunoassay |
Vk_20200124_20 |
|
19.03.2020 |
Biomet Orthopaedics, LLC |
StageOne Hip Cement Spacer Mold, |
MD: Orthopaedic cement spacer mould |
Vk_20200313_09 |
|
16.03.2020 |
GGT Holding BV |
Telefunken / HeartReset |
MD: AED, automated external defibrillator |
Vk_20200311_20 |
|
13.03.2020 |
WRP Asia Pacific |
Dermagrip Ellbogen-Handschuh |
MD: Hevea-latex surgical glove, non-powdered |
Vk_20200313_11 |
|
10.03.2020 (Updated 12.03.2020) |
Siemens Healthcare Diagnostics Products GmbH |
N Latex CDT |
IVD: Transferrin kit |
Vk_20200305_12 |
|
12.03.2020 |
Siemens Healthcare Diagnostics Inc. |
Atellica CH 930 Analyzer |
IVD: Chemiluminescent immunoassay analyser IVD, automated |
Vk_20200303_05 |
|
11.03.2020 |
Mint Medical GmbH |
mint Lesion |
MD: Picture archiving and communication systems (PACS), radiology |
Vk_20200306_10 |
|
09.03.2020 (Updated 11.03.2020) |
Mölnlycke Health Care AB |
Optical Trocar 12mm/100mm Universal Trocar Cannula 12mm / 100mm |
MD: Endotherapy trocar, single-use MD: Endotherapy trocar, single-use |
Vk_20200227_07 |
|
10.03.2020 |
Boston Scientific Corporation |
Sensor |
MD: Gastro-urological guidewire, single-use |
Vk_20200309_10 |
|
10.03.2020 |
WITTENSTEIN intens GmbH |
FITBONE Receiver |
AIMD: Long bone distraction rod receiver |
Vk_20200228_04 |
|
06.03.2020 |
Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK) |
Olympic Brainz Monitor |
MD: Electroencephalograph |
Vk_20200303_01 |
|
06.03.2020 |
Cryopal |
CONTAINERS , CRYO BIOLOGICAL STORAGE |
MD: Cryobiological storage container |
Vk_20200213_10 |
|
06.03.2020 |
Cryopal |
Arpege |
MD: Cryobiological storage container |
Vk_20200213_09 |
|
05.03.2020 |
Advanced Bionics AG |
HiRes Ultra / HiRes Ultra 3D |
AIMD: Cochlear implant system electrode array assembly |
Vk_20200218_02 |
|
05.03.2020 |
Medtron AG |
MR-Set ELS 65ml |
MD: Double-Axis Electrogoniometers |
Vk_20200213_16 |
|
04.03.2020 |
Zimmer Biomet GmbH |
Anatomical Shoulder Trial Humeral PE-Insert |
MD: Joint prosthesis implantation kit, reusable |
Vk_20200228_07 |
|
04.03.2020 |
Beckman Coulter Ireland, Inc. |
iChem VELOCITY Urine Chemistry Strips |
IVD: Urine rapid test device, multiple-constituent |
Vk_20200227_15 |