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

PDF430KB

Urgent field safety notice for Estech COBRA Fusion Ablation System, AtriCure Inc.

Medical electronics / Electromedical devices – electrotherapy

PDF223KB

Urgent field safety notice for Biograph mCT and mCT Flow, Siemens Medical Solutions Inc.

Radiological technology – equipment for nuclear medical functional and localisation diagnostics

PDF119KB

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

PDF398KB

Urgent field safety notice for the SynchroMed® implantable infusion pump, Medtronic GmbH

Active implantable medical devices – drug pumps

PDF131KB

Lot recall of Fortune Medical Silicone Resuscitators, Weimann Emergency Medical Technology GmbH

Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply

PDF161KB

Urgent field safety notice for IQon Spectral CT, Philips Medical Systems Inc.

Radiological technology – CT scanners

PDF390KB

Urgent field safety notice for Spectral Diagnostic Suite, Philips Healthcare

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

PDF399KB

Recall of Ultra System® Sterilization Containers, Symmetry Surgical Inc.

General equipment for medical treatment – cleaning / disinfection / sterilisation

PDF718KB

Lot recall for Artiset HD SN HC and Artiset HD DNL HC, Baxter GmbH

Injections / Infusions / Transfusions / Dialysis – dialysis technology

PDF186KB

Urgent field safety notice for NX image processing software, Agfa HealthCare N.V.

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

PDF124KB

Urgent field safety notice for Monaco® RTP System, ELEKTA AB

Radiotherapy / Radiation protection – radiotherapy treatment planning systems

PDF153KB

Urgent field safety notice for CARAT I pro and CARAT II pro Ventilators, Hoffrichter GmbH

Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply

PDF272KB

Lot recall of Imager™ II Angiographic Catheter, Boston Scientific International S.A.

Injections / Infusions / Transfusions / Dialysis – catheters

PDF624KB

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

PDF26KB

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

PDF827KB

Urgent field safety notice for Human Milk Analyser, MIRIS AB

In-vitro diagnostics – instruments, apparatuses and systems

PDF138KB

Urgent field safety notice for MicroTrak® Chlamydia trachomatis Direct Specimen Collection Kit, Trinity Biotech

In-vitro diagnostics – microbiological products

PDF3MB

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

PDF150KB

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

PDF97KB

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

PDF102KB

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

PDF159KB

Lot recall of position headed reamer scaled D8.0mm, Aesculap AG

Medical instruments for use in humans – bone surgery

PDF59KB

Recall of Inpactor for PFNA Blade, DePuy Synthes

Medical instruments for use in humans – bone surgery

PDF87KB

Lot recall of Screwdriver handle/ T-shape/ cannulated, Zimmer Biomet

Medical instruments for use in humans – bone surgery

PDF190KB

Lot recall of K-wire Ø1,2 mm L100 mm trocar tip non-sterile, Biotech Ortho / Wright

Non-active implants – bone surgery

PDF164KB

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

PDF514KB

Urgent field safety notice for Oxylog 3000 / plus, Drägerwerk AG & Co. KGaA

Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply

PDF184KB

Recall of Arthrex S3 Arm Sleeve Connector, Allen Medical / Hill-Rom SAS

Surgical equipment/ Anaesthesia – surgical equipment

PDF169K

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

PDF148KB

Batch recall of NewBreez intralaryngeal prosthesis, PROTiP Medical

Non-active implants – special implants

PDF108KB

Batch recall of sleep safe Sets, Fresenius Medical Care

Injections / Infusions / Transfusions / Dialysis – dialysis technology

PDF148KB

Urgent field safety notice for CentraLink Data Management System, Siemens Healthcare Diagnostics Inc.

Medical electronics / Electromedical devices – electrodiagnostics

PDF27KB

Urgent field safety notice for iPlan RT / iPlan RT Dose / BrainSCAN, Brainlab AG

Radiotherapy / Radiation protection – radiotherapy treatment planning systems

PDF407KB

Lot recall of multiflex guidewire, UROMED Kurt Drews KG

Injections / Infusions / Transfusions / Dialysis – catheters

PDF285KB

Urgent field safety notice for Artis zee, Artis Q and Artis Q.zen, Siemens Healthcare GmbH

Radiological technology – radiological equipment for vascular diagnostics

PDF39KB

Urgent field safety notice for oneHbA1c IS, DiaSys Diagnostic Systems GmbH

In-vitro diagnostics – equipment / products for clinical chemistry

PDF149KB

Lot recall of Titanium Bone Screws, Anton Hipp GmbH

Non-active implants – bone surgery

PDF410KB

Urgent field safety notice for Heater cooler 1T / 3T / FlexTherm, Sorin Group Deutschland GmbH / LivaNova PLC

Surgical equipment/ Anaesthesia – surgical equipment

PDF728KB

Urgent field safety notice for cobas b 123 <3> and <4> system, Roche Diagnostics GmbH

In-vitro diagnostics – equipment / products for clinical chemistry

PDF240KB

Urgent field safety notice for Heater Unit HCU 40, Maquet Cardiopulmonary GmbH

Surgical equipment/ Anaesthesia – surgical equipment

PDF498KB

Urgent field safety notice for Heater Unit HU 35, Maquet Cardiopulmonary GmbH

Surgical equipment/ Anaesthesia – surgical equipment

PDF88KB

Lot recall of Alegria Anti-Instrinsic Factor / Anti-Mycoplasma pneumoniae IgM Abs., Orgentec Diagnostika GmbH

In-vitro diagnostics – microbiological products

PDF47KB

Recall of INRatio and INRatio 2 PT / INR Monitoring System, Alere

In-vitro diagnostics – haematological, histological and cytological products

PDF533KB

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

PDF399KB

Urgent field safety notice for Compact Suction Unit 4 (LCSU 4), Laerdal Medical AS

Surgical equipment/ Anaesthesia – surgical equipment

PDF603KB

Urgent field safety notice for ORTHO VISION Max / Analyzer for ORTHO BioVue Cassettes, Ortho Clinical Diagnostics

In-vitro diagnostics – equipment / products for clinical chemistry

PDF192KB

Recall of NRG transseptal needle, Baylis Medical Company Inc.

Medical electronics / Electromedical devices – electrodiagnostics

PDF181KB

Lot recall of INGEVITY™ MRI, Boston Scientific International S. A.

Active implantable medical devices – cardiac pacemakers

PDF240KB

Lot recall of Celt ACD Femoral Artery Vascular Closure Device 5F and 6F, Vaserum Ltd.

Non-active implants – special implants

PDF718KB

Urgent field safety notice for NanoZoomer Digital Pathology Scanners, Hamamatsu Photonics Deutschland GmbH

In-vitro diagnostics – instruments, apparatuses and systems

PDF283KB

Urgent Field Safey Notice for CyberKnife Systems with software version 10.6, Accuray International

Radiotherapy / Radiation protection – radiotherapy treatment planning systems

PDF78KB

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

PDF443KB

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

PDF523KB

Lot recall of guidewire UKKS-35150, Sana-one GmbH

Injections / Infusions / Transfusions / Dialysis – catheters

PDF59KB

Recall of Gender Solutions PFJ Milling Handpiece, Zimmer Biomet / Zimmer GmbH

Medical electronics / Electromedical devices – electrotherapy

PDF427KB

Urgent field safety notice for shaft rasp A2, ImplanTec Deutschland GmbH

Medical instruments for use in humans – bone surgery

PDF379KB

Lot recall of 20ul Clear RoboRack Tip, PerkinElmer Health Sciences

In-vitro diagnostics – equipment / products for clinical chemistry

PDF464KB

Lot recall of EMIT Ethosuximide Assay, Siemens Healthcare Diagnostics Inc.

In-vitro diagnostics – equipment / products for clinical chemistry

PDF26KB

Lot recall of IMMULITE / 1000 Turbo D-Dimer assay, Siemens Healthcare Diagnostics Inc.

In-vitro diagnostics – haematological, histological and cytological products

PDF56KB

Lot recall of IMMULITE / 1000 Homocysteine assay, Siemens Healthcare Diagnostics Inc.

In-vitro diagnostics – equipment / products for clinical chemistry

PDF65KB

Urgent field safety notice for Nellix EndoVascular Aneurysm Sealing System, Endologix International Holdings B.V.

Non-active implants – other implants

PDF456KB

Urgent field safety notice for Gemini, Dornier Med Tech Systems GmbH

Ultrasonics – ultrasonic therapeutic equipment

PDF44KB

Batch recall of bone subsitute and cervical cage, KASIOS SAS

Non-active implants – bone surgery

PDF55KB

Urgent field safety notice for ROTEM sigma cartridges complete + hep, Tem Innovations GmbH

In-vitro diagnostics – haematological, histological and cytological products

PDF192KB

 

 

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