Інформація, отримана з іноземних систем повідомлення про продукцію, що становить серйозний ризик, за період 01.04.2019 – 30.06.2019

Німеччина

 

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• 06.28

Urgent Field Safety Notice for Neutrogena Light Therapy Acne Mask and Refill by Johnson & Johnson GmbH

Physical therapy – phototherapy

PDF34KB

• 06.28

Urgent Field Safety Notice for Nucleus Hydrodissector [Sauter] 40x22mm(27Gx7/8in) by Beaver-Visitec International, Inc

Medical instruments for use in humans – eye surgery

PDF135KB

• 06.28

Urgent Field Safety Notice for Solar Blue by Medical Measurement Systems B.V.

Medical electronics / Electromedical devices – electrodiagnostics

PDF2MB

• 06.28

Urgent Field Safety Notice for Ultra-Drive Hose/Drape/Tubing Assembly by Biomet Orthopedics, LLC

Surgical equipment/ Anaesthesia – surgical equipment

PDF217KB

• 06.28

Urgent Field Safety Notice for LEGION Optima Cutting Block by Smith & Nephew Orthopaedics AG

Medical instruments for use in humans – bone surgery

PDF107KB

• 06.27

Urgent Field Safety Notice for Prismaflex by Gambro Lundia AB

Injections / Infusions / Transfusions / Dialysis – dialysis technology

PDF218KB

• 06.27

Urgent Field Safety Notice for Besteck zur Katheterisierung von Arterien by Teleflex Medical USA

Injections / Infusions / Transfusions / Dialysis – catheters

PDF144KB

• 06.26

Urgent Field Safety Notice for HexaPOD evo RT System / Medical Intelligence Mediz by Elekta | Medical Intelligence Medizintechnik GmbH

Surgical equipment/ Anaesthesia – surgical equipment

PDF751KB

• 06.26

Urgent Field Safety Notice for HeartStart MRx by Philips Healthcare

Medical electronics / Electromedical devices – electrotherapy

PDF308KB

• 06.26

Urgent Field Safety Notice for Perfusor Space 12V-Anschlussleitung by B. Braun Melsungen AG

Injections / Infusions / Transfusions / Dialysis – infusion technology

PDF373KB

• 06.25

Urgent Field Safety Notice for TECOTHERM NEO by TEC COM GmbH

Surgical equipment/ Anaesthesia – surgical equipment

PDF42KB

• 06.24

Urgent Field Safety Notice for AEROtube® – LK02-GB-M by Surgimax Instruments

Optics / Precision engineering – medical microscopes (does not incude laboratory microscopes)

PDF7MB

• 06.24

Urgent Field Safety Notice for Zoll AED PRO Defibrillator by ZOLL Medical Corporation

Medical electronics / Electromedical devices – electrotherapy

PDF217KB

• 06.24

Urgent Field Safety Notice for Vasco-OP Sensitive by B.Braun Avitum AG

General equipment for medical treatment – auxiliary equipment

PDF38KB

• 06.21

Urgent Field Safety Notice for Elekta Unity by Elekta Ltd

Radiotherapy / Radiation protection – radiation facilites with accelerators for teletherapy

PDF87KB

• 06.19

Urgent Field Safety Notice for Barricaid by Intrinsic Therapeutics, Inc.

Non-active implants – bone surgery

PDF162KB

• 06.19

Urgent Field Safety Notice for Titanium abutment cemented GH 5.5 mm by Hager & Meisinger GmbH

Dental products – dental implants

PDF143KB

• 06.19

Urgent Field Safety Notice for GelPOINT® Path Transanal Access Platform by Applied Medical Resources

Dressings / Pads – others

PDF108KB

• 06.19

Urgent Field Safety Notice for Endo GIA Surgical Stapling Single Use Loading Units, Tri-Staple 2.0 Intelligent Reloads and Cartridges by Covidien llc

Medical instruments for use in humans – general instruments

PDF233KB

• 06.19

Urgent Field Safety Notice for DVR Express Disposable Instruments by Zimmer Inc.

Medical instruments for use in humans – bone surgery

PDF366KB

• 06.18

Urgent Field Safety Notice for MicroVue C4d Fragment EIA by Quidel Corporation Athens

In-vitro diagnostics – equipment / products for clinical chemistry

PDF277KB

• 06.18

Urgent Field Safety Notice for TruCal U by DiaSys Diagnostic Systems GmbH

In-vitro diagnostics – equipment / products for clinical chemistry

PDF2MB

• 06.18

Urgent Field Safety Notice for Alinity ci-series System Control Module (SCM) by Abbott GmbH & Co. KG

In-vitro diagnostics – equipment / products for clinical chemistry

PDF250KB

• 06.18

Urgent Field Safety Notice for HUMAN ASSAYED MULTI-SERA Level 2 by Randox Laboratories Ltd

In-vitro diagnostics – equipment / products for clinical chemistry

PDF2MB

• 06.18

Urgent Field Safety Notice for Alinity ci-series System Control Module (SCM) by Abbott GmbH & Co. KG

In-vitro diagnostics – equipment / products for clinical chemistry

PDF119KB

• 06.18

Urgent Field Safety Notice for ARCHITECT BNP Calibrator kit and ARCHITECT BNP Control kit by Abbott Laboratories (Abbott Park)

In-vitro diagnostics – equipment / products for clinical chemistry

PDF135KB

• 06.18

Urgent Field Safety Notice for RF electrosurgical unit for arthroscopy by EMED S.. Z O.O.SP.K.

Medical electronics / Electromedical devices – electrotherapy

PDF901KB

• 06.18

Urgent Field Safety Notice for Assayed Bovine Multi-Sera – Level 1 by Randox Laboratories Ltd

In-vitro diagnostics – equipment / products for clinical chemistry

PDF1MB

• 06.18

Urgent Field Safety Notice for Hemoglobin A1c Calibrators by Abbott Laboratories

In-vitro diagnostics – equipment / products for clinical chemistry

PDF124KB

• 06.18

Urgent Field Safety Notice for Stratus® CS Acute CareTM CTNI TestPak by Siemens Healthcare Diagnostics Inc.

In-vitro diagnostics – immunological products

PDF410KB

• 06.18

Urgent Field Safety Notice for Elecsys Syphilis (200 test/kit) by Roche Diagnostics GmbH

In-vitro diagnostics – microbiological products

PDF251KB

• 06.18

Urgent Field Safety Notice for EliA RF IgM Well by Phadia AB

In-vitro diagnostics – immunological products

PDF76KB

• 06.18

Urgent Field Safety Notice for AssayTip / AssayCup by Roche Diagnostics GmbH

In-vitro diagnostics – equipment / products for clinical chemistry

PDF457KB

• 06.18

Urgent Field Safety Notice for FluoroSoftware IVD used with FluoroCyclers 12 & 96 by Hain Lifescience GmbH

In-vitro diagnostics – equipment / products for clinical chemistry

PDF102KB

• 06.18

Urgent Field Safety Notice for BD Microtainer Röhrchen by Becton Dickinson and Company

In-vitro diagnostics – instruments, apparatuses and systems

PDF175KB

• 06.18

Urgent Field Safety Notice for IGA-2 (Tina-quant IgA Gen.2) by Roche Diagnostics GmbH

In-vitro diagnostics – immunological products

PDF312KB

• 06.18

Urgent Field Safety Notice for Alinity i BNP Calibrators and Alinity i BNP Controls by Abbott International RA Vigilance Team

In-vitro diagnostics – equipment / products for clinical chemistry

PDF120KB

• 06.18

Urgent Field Safety Notice for Quo-Lab A1C Test Kit / PocketChem HbA1Cc Test Kit by EKF-diagnostic GmbH

In-vitro diagnostics – equipment / products for clinical chemistry

PDF4MB

• 06.18

Urgent Field Safety Notice for Chocolat PolyViteX (PVX) by bioMérieux S. (Marcy- l’Etoile)

In-vitro diagnostics – microbiological products

PDF337KB

• 06.18

Urgent Field Safety Notice for No. sterile pin guide by TORNIER SAS

Surgical equipment/ Anaesthesia – surgical equipment

PDF7MB

• 06.18

Urgent Field Safety Notice for G-6-PDH Control Deficient and Normal by Randox Laboratories Ltd

In-vitro diagnostics – equipment / products for clinical chemistry

PDF1MB

• 06.18

Urgent Field Safety Notice for MicroVue DPD EIA by Quidel Corporation Athens

In-vitro diagnostics – equipment / products for clinical chemistry

PDF249KB

• 06.18

Urgent Field Safety Notice for Alinity c Complement C3 Reagent, Alinity c Immunoglobulin A Reagent; Alinity c Immunoglobulin G Reagent; Alinity c Immunoglobulin M Reagent; Alinity c Apolipoprotein A1 Reagent; Al by Abbott Laboratories (Abbott Park)

In-vitro diagnostics – immunological products

PDF108KB

• 06.18

Urgent Field Safety Notice for Div. Produkte by Immundiagnostik AG

In-vitro diagnostics – equipment / products for clinical chemistry

PDF2MB

• 06.18

Urgent Field Safety Notice for VITROS Chemistry Products CK Slides by Ortho Clinical Diagnostics Inc

In-vitro diagnostics – equipment / products for clinical chemistry

PDF1MB

• 06.18

Urgent Field Safety Notice for ARCHITECT Complement C3; ARCHITECT Immunoglobulin A; ARCHITECT Immunoglobulin G; ARCHITECT Immunoglobulin M; ARCHITECT Apolipoprotein A1;ARCHITECT Complement C4; ARCHITECT Haptoglo by Abbott Laboratories (Abbott Park)

In-vitro diagnostics – immunological products

PDF123KB

• 06.18

Urgent Field Safety Notice for AUTION HYBRID AU-4050 by Arkray Factory, Inc.

In-vitro diagnostics – equipment / products for clinical chemistry

PDF1MB

• 06.17

Urgent Field Safety Notice for British standard power cord DA8K-10-14453 by SHENZSHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD

Medical electronics / Electromedical devices – electrodiagnostics

PDF197KB

• 06.17

Urgent Field Safety Notice for British standard power cord DA8K-10-14453 by SHENZSHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD

Medical electronics / Electromedical devices – electrodiagnostics

PDF197KB

• 06.17

Urgent Field Safety Notice for Diverse Instruments by Dedienne Santé

Medical instruments for use in humans – bone surgery

PDF355KB

• 06.17

Urgent Field Safety Notice for Philips PageWriter TC Cardiographs (TC20/30/50/70) by Philips Medical Systems

Medical electronics / Electromedical devices – electrodiagnostics

PDF1MB

• 06.17

Urgent Field Safety Notice for Cios Alpha and Cios Fusion by Siemens Healthcare GmbH, X-Ray Products (XP)

Radiological technology – mobile radiological diagnostic facilities

PDF634KB

• 06.17

Urgent Field Safety Notice for Advance Enforcer 35 Focal Force PTA Balloon Catheter by Cook Inc.

Injections / Infusions / Transfusions / Dialysis – catheters

PDF91KB

• 06.14

Urgent Field Safety Notice for Hudson RCI Air Cushion Face Mask by Teleflex Medical USA

Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply

PDF152KB

• 06.14

Urgent Field Safety Notice for Intraclude device by Edwards Lifesciences Utah

Injections / Infusions / Transfusions / Dialysis – catheters

PDF257KB

• 06.13

Urgent Field Safety Notice for Occlutech Delivery Set by Occlutech GmbH

Non-active implants – cardiac surgery

PDF7MB

• 06.12

Urgent Field Safety Notice for FS 2-21, FS 2-25 und FS 3-45 by Möller-Wedel GmbH & Co. KG

Optics / Precision engineering – medical microscopes (does not incude laboratory microscopes)

PDF135KB

• 06.12

Urgent Field Safety Notice for Artis zee/Artis Q by Siemens Healthcare GmbH Advanced Therapies

Radiological technology – radiological equipment for vascular diagnostics

PDF816KB

• 06.11

Urgent Field Safety Notice for Pleur Evac Infant Sahara Dr. by Teleflex Medical USA

Surgical equipment/ Anaesthesia – surgical equipment

PDF179KB

• 06.11

Urgent Field Safety Notice for Centricity Universal Viewer by GEHEALTHCARE INTEGRATED IT SOLUTIONS Inc

Medical data processing (software) – data processing facilities for image processing

PDF210KB

• 06.11

Urgent Field Safety Notice for Centricity Universal Viewer with CPACS Foundations by GE Healthcare

Medical data processing (software) – data processing facilities for image processing

PDF206KB

• 06.11

Urgent Field Safety Notice for Vscan Extend by GE Vingmed Ultrasound A/S

Ultrasonics – ultrasonic diagnostic equipment

PDF158KB

• 06.11

Urgent Field Safety Notice for Horizon/McKesson Cardiology Hemo by Change Healthcare Israel Ltd

Radiological technology – radiological equipment for vascular diagnostics

PDF82KB

• 06.11

Urgent Field Safety Notice for Senographe Pristina and Pristina Serena by GE Medical Systems SCS

Radiological technology – radiological equipment for mammographic diagnostics

PDF323KB

• 06.07

Urgent Field Safety Notice for DISP.FLEECE DRAPE F/GA419/GD417/GD421 by Aesculap AG

Surgical equipment/ Anaesthesia – surgical equipment

PDF264KB

• 06.06

Urgent Field Safety Notice for VNS Therapy SenTiva Generator by LivaNova, Inc

Active implantable medical devices – biostimulators

PDF140KB

• 06.05

Urgent Field Safety Notice for elisa 800 by Löwenstein Medical Innovation GmbH & Co. KG

Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply

PDF171KB

• 06.04

Urgent Field Safety Notice for Centricity PACS IW by GEHEALTHCARE INTEGRATED IT SOLUTIONS Inc

Radiological technology – auxiliary equipment and supplies for radiology / nuclear medicine

PDF204KB

• 06.04

Urgent Field Safety Notice for EPi-Sense Coagulation System with Visitrax by AtriCure, Inc. – Mason

Medical electronics / Electromedical devices – electrotherapy

PDF293KB

• 06.04

Urgent Field Safety Notice for SLIM Handle by Pega Medical, Inc.

Medical instruments for use in humans – bone surgery

PDF241KB

• 06.04

Urgent Field Safety Notice for EQUISTREAM, EQUISTREAM XK, and GLIDEPATH by Bard Access Systems Division (BASD)

Injections / Infusions / Transfusions / Dialysis – catheters

PDF187KB

• 06.04

Urgent Field Safety Notice for Healing Abutment CC RP Ø3.6x5mm by Nobel Biocare AB

Dental products – dental implants

PDF55KB

• 06.04

Urgent Field Safety Notice for ZOLL Pro-padz Radiolucent Electrode by ZOLL Medical Corporation

Medical electronics / Electromedical devices – electrotherapy

PDF196KB

• 06.04

Urgent Field Safety Notice for BIOSAFE MD-smart by CryothermGmbH & Co. KG

General equipment for medical treatment – furnishings

PDF311KB

• 06.03

Urgent Field Safety Notice for Efficia 3/5 ECG Trunk Cable, AAMI/IEC by Philips Medical Systems

Medical electronics / Electromedical devices – electrotherapy

PDF7MB

• 06.03

Urgent Field Safety Notice for O-ARM Imaging System by Medtronic Navigation Inc.

Radiological technology – navigation systems

PDF842KB

• 06.03

Urgent Field Safety Notice for LED Surgical Light by NANJING MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Surgical equipment/ Anaesthesia – surgical equipment

PDF85KB

• 06.03

Urgent Field Safety Notice for Sensation Plus 7.5Fr 40cc by Datascope Corporation

Injections / Infusions / Transfusions / Dialysis – catheters

PDF60KB

• 05.29

Urgent Field Safety Notice for SOLOPATH® Expandable, SOLOPATH® Re-collapsible by Terumo Medical Corp.

Injections / Infusions / Transfusions / Dialysis – catheters

PDF184KB

• 05.29

Urgent Field Safety Notice for Cera Plug by Lifetech Scientific Co.LTD

Non-active implants – special implants

PDF7MB

• 05.29

Urgent Field Safety Notice for EVIS EXERA(Q190V)-/LUCERA(Q290V) DUODENOVIDEOSCOPE by Olympus Medical Systems Corp.

Optics / Precision engineering – endoscopes

PDF221KB

• 05.29

Urgent Field Safety Notice for Guardian Connect Application by Medtronic Minimed

Medical data processing (software) – others

PDF240KB

• 05.29

Urgent Field Safety Notice for Sinapi Thoraxdrainage-System by Primed Halberstadt Medizintechnik GmbH

Injections / Infusions / Transfusions / Dialysis – drainages and suction systems

PDF3MB

• 05.28

Urgent Field Safety Notice for AXIOM Artis/Artis zee by Siemens Healthcare GmbH Advanced Therapies

Radiological technology – radiological equipment for vascular diagnostics

PDF669KB

• 05.28

Urgent Field Safety Notice for Prismaflex Sets by GAMBRO DASCO FR

Injections / Infusions / Transfusions / Dialysis – dialysis technology

PDF53KB

• 05.28

Urgent Field Safety Notice for Prismaflex Sets by GAMBRO DASCO FR

Injections / Infusions / Transfusions / Dialysis – dialysis technology

PDF53KB

• 05.28

Urgent Field Safety Notice for MARS Treatment Kit by Gambro Lundia AB

Injections / Infusions / Transfusions / Dialysis – dialysis technology

PDF53KB

• 05.28

Urgent Field Safety Notice for Synergy Cranial, StealthStation Cranial by Medtronic Navigation Inc.

Radiological technology – navigation systems

PDF576KB

• 05.28

Urgent Field Safety Notice for EKOS Control System 4.0 by EKOS Corporation

Ultrasonics – ultrasonic diagnostic equipment

PDF439KB