Людям із порушенням зору 
In English Інформація, отримана з іноземних систем повідомлення про продукцію, що становить серйозний ризик, за період 01.12.2016 – 31.12.2016
Опубліковано 03.01.2017 о 00:00
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Recall of AFX™ Endovascular AAA System, Endologix
Non-active implants – special implants
Urgent field safety notice for Estech COBRA Fusion Ablation System, AtriCure Inc.
Medical electronics / Electromedical devices – electrotherapy
Urgent field safety notice for Biograph mCT and mCT Flow, Siemens Medical Solutions Inc.
Radiological technology – equipment for nuclear medical functional and localisation diagnostics
Urgent field safety notice for Claria MRI™ CRT-D Sure Scan™ and Amplia MRI™ CRT-D Sure Scan™, Medtronic GmbH
Active implantable medical devices – defibrillators
Urgent field safety notice for the SynchroMed® implantable infusion pump, Medtronic GmbH
Active implantable medical devices – drug pumps
Lot recall of Fortune Medical Silicone Resuscitators, Weimann Emergency Medical Technology GmbH
Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply
Urgent field safety notice for IQon Spectral CT, Philips Medical Systems Inc.
Radiological technology – CT scanners
Urgent field safety notice for Spectral Diagnostic Suite, Philips Healthcare
Medical data processing (software) – data processing facilities for image processing
Recall of Ultra System® Sterilization Containers, Symmetry Surgical Inc.
General equipment for medical treatment – cleaning / disinfection / sterilisation
Lot recall for Artiset HD SN HC and Artiset HD DNL HC, Baxter GmbH
Injections / Infusions / Transfusions / Dialysis – dialysis technology
Urgent field safety notice for NX image processing software, Agfa HealthCare N.V.
Radiological technology – auxiliary equipment and supplies for radiology / nuclear medicine
Urgent field safety notice for Monaco® RTP System, ELEKTA AB
Radiotherapy / Radiation protection – radiotherapy treatment planning systems
Urgent field safety notice for CARAT I pro and CARAT II pro Ventilators, Hoffrichter GmbH
Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply
Lot recall of Imager™ II Angiographic Catheter, Boston Scientific International S.A.
Injections / Infusions / Transfusions / Dialysis – catheters
Lot recall of RIA Tube Assembly, for RIA Drive Shaft minimum length 520 mm, for No. 314.743, sterile, DePuy Synthes
Medical instruments for use in humans – bone surgery
Lot recall of ARCHITECT Active-B12 Reagent Kit, Abbott
In-vitro diagnostics – equipment / products for clinical chemistry
Urgent field safety notice for ORTHO VISION® Analyzers with software version 3.6.0 and below, Ortho-Clinical Diagnostics
In-vitro diagnostics – equipment / products for clinical chemistry
Urgent field safety notice for Human Milk Analyser, MIRIS AB
In-vitro diagnostics – instruments, apparatuses and systems
Urgent field safety notice for MicroTrak® Chlamydia trachomatis Direct Specimen Collection Kit, Trinity Biotech
In-vitro diagnostics – microbiological products
Urgent field safety notice for PreciControl Varia, Level 2 – Elecsys® PTH assay on Elecsys® 2010 / cobas e 411, Roche Diagnostics GmbH
In-vitro diagnostics – equipment / products for clinical chemistry
Urgent field safety notice for QuikRead FOB Sampling-Set / QuikRead FOB quantitativ-Kit and QuikRead go iFOBT-Kit, Orion Diagnostika
In-vitro diagnostics – equipment / products for clinical chemistry
Urgent field safety notice for Source Administration Sets (SAS) used with the Medrad® Intego PET Infusion System (Catalog Number INT CSS), Bayer Medical Care Inc.
Injections / Infusions / Transfusions / Dialysis – infusion technology
Lot recall of Instrumentation for E.T.O.I.L.E® system – E.T.O.I.L.E® extension table (leg holder), Amplitude S.A.S
Medical instruments for use in humans – bone surgery
Lot recall of position headed reamer scaled D8.0mm, Aesculap AG
Medical instruments for use in humans – bone surgery
Recall of Inpactor for PFNA Blade, DePuy Synthes
Medical instruments for use in humans – bone surgery
Lot recall of Screwdriver handle/ T-shape/ cannulated, Zimmer Biomet
Medical instruments for use in humans – bone surgery
Lot recall of K-wire Ø1,2 mm L100 mm trocar tip non-sterile, Biotech Ortho / Wright
Non-active implants – bone surgery
Urgent field safety notice for instruments and containers: Java pedicle screw system / Fidji cervical / lumbar cage / Wallis posterior dynamic stabilization system, Zimmer Biomet
Medical instruments for use in humans – bone surgery
Urgent field safety notice for Oxylog 3000 / plus, Drägerwerk AG & Co. KGaA
Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply
Recall of Arthrex S3 Arm Sleeve Connector, Allen Medical / Hill-Rom SAS
Surgical equipment/ Anaesthesia – surgical equipment
Urgent field safey notice for Atrium Ocean / Oasis / Express / Express Mini chest drainage products, Maquet Getinge Group
Injections / Infusions / Transfusions / Dialysis – drainages and suction systems
Batch recall of NewBreez intralaryngeal prosthesis, PROTiP Medical
Non-active implants – special implants
Batch recall of sleep safe Sets, Fresenius Medical Care
Injections / Infusions / Transfusions / Dialysis – dialysis technology
Urgent field safety notice for CentraLink Data Management System, Siemens Healthcare Diagnostics Inc.
Medical electronics / Electromedical devices – electrodiagnostics
Urgent field safety notice for iPlan RT / iPlan RT Dose / BrainSCAN, Brainlab AG
Radiotherapy / Radiation protection – radiotherapy treatment planning systems
Lot recall of multiflex guidewire, UROMED Kurt Drews KG
Injections / Infusions / Transfusions / Dialysis – catheters
Urgent field safety notice for Artis zee, Artis Q and Artis Q.zen, Siemens Healthcare GmbH
Radiological technology – radiological equipment for vascular diagnostics
Urgent field safety notice for oneHbA1c IS, DiaSys Diagnostic Systems GmbH
In-vitro diagnostics – equipment / products for clinical chemistry
Lot recall of Titanium Bone Screws, Anton Hipp GmbH
Non-active implants – bone surgery
Urgent field safety notice for Heater cooler 1T / 3T / FlexTherm, Sorin Group Deutschland GmbH / LivaNova PLC
Surgical equipment/ Anaesthesia – surgical equipment
Urgent field safety notice for cobas b 123 <3> and <4> system, Roche Diagnostics GmbH
In-vitro diagnostics – equipment / products for clinical chemistry
Urgent field safety notice for Heater Unit HCU 40, Maquet Cardiopulmonary GmbH
Surgical equipment/ Anaesthesia – surgical equipment
Urgent field safety notice for Heater Unit HU 35, Maquet Cardiopulmonary GmbH
Surgical equipment/ Anaesthesia – surgical equipment
Lot recall of Alegria Anti-Instrinsic Factor / Anti-Mycoplasma pneumoniae IgM Abs., Orgentec Diagnostika GmbH
In-vitro diagnostics – microbiological products
Recall of INRatio and INRatio 2 PT / INR Monitoring System, Alere
In-vitro diagnostics – haematological, histological and cytological products
Lot recall of i-PRF Tubes 10 mL, Process for PRF / ALL YOUNG
Injections / Infusions / Transfusions / Dialysis – equipment for collecting blood products and peripheral stem cells
Urgent field safety notice for Compact Suction Unit 4 (LCSU 4), Laerdal Medical AS
Surgical equipment/ Anaesthesia – surgical equipment
Urgent field safety notice for ORTHO VISION Max / Analyzer for ORTHO BioVue Cassettes, Ortho Clinical Diagnostics
In-vitro diagnostics – equipment / products for clinical chemistry
Recall of NRG transseptal needle, Baylis Medical Company Inc.
Medical electronics / Electromedical devices – electrodiagnostics
Lot recall of INGEVITY™ MRI, Boston Scientific International S. A.
Active implantable medical devices – cardiac pacemakers
Lot recall of Celt ACD Femoral Artery Vascular Closure Device 5F and 6F, Vaserum Ltd.
Non-active implants – special implants
Urgent field safety notice for NanoZoomer Digital Pathology Scanners, Hamamatsu Photonics Deutschland GmbH
In-vitro diagnostics – instruments, apparatuses and systems
Urgent Field Safey Notice for CyberKnife Systems with software version 10.6, Accuray International
Radiotherapy / Radiation protection – radiotherapy treatment planning systems
Urgent field safety notice for CRT monitors Prestige 2 / Prestilix / Prestige VH / Prestige SI / RFX/SFX / Legacy / Precision 500D / ADVANTX / Innova 2000, GE Healthcare
Radiological technology – stationary radiological equipment
Lot recall of Primara SF Pfanne Ø48 (XX/39G) / Ø50 (XX/39G) / Ø52 (XX/44G) / Ø56 (XX/48G), OHST Medizintechnik AG
Non-active implants – bone surgery
Lot recall of guidewire UKKS-35150, Sana-one GmbH
Injections / Infusions / Transfusions / Dialysis – catheters
Recall of Gender Solutions PFJ Milling Handpiece, Zimmer Biomet / Zimmer GmbH
Medical electronics / Electromedical devices – electrotherapy
Urgent field safety notice for shaft rasp A2, ImplanTec Deutschland GmbH
Medical instruments for use in humans – bone surgery
Lot recall of 20ul Clear RoboRack Tip, PerkinElmer Health Sciences
In-vitro diagnostics – equipment / products for clinical chemistry
Lot recall of EMIT Ethosuximide Assay, Siemens Healthcare Diagnostics Inc.
In-vitro diagnostics – equipment / products for clinical chemistry
Lot recall of IMMULITE / 1000 Turbo D-Dimer assay, Siemens Healthcare Diagnostics Inc.
In-vitro diagnostics – haematological, histological and cytological products
Lot recall of IMMULITE / 1000 Homocysteine assay, Siemens Healthcare Diagnostics Inc.
In-vitro diagnostics – equipment / products for clinical chemistry
Urgent field safety notice for Nellix EndoVascular Aneurysm Sealing System, Endologix International Holdings B.V.
Non-active implants – other implants
Urgent field safety notice for Gemini, Dornier Med Tech Systems GmbH
Ultrasonics – ultrasonic therapeutic equipment
Batch recall of bone subsitute and cervical cage, KASIOS SAS
Non-active implants – bone surgery
Urgent field safety notice for ROTEM sigma cartridges complete + hep, Tem Innovations GmbH
In-vitro diagnostics – haematological, histological and cytological products
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