Аналіз інформації за період 01.04.2016 – 30.04.2016, отриманої з іноземних систем повідомлення про продукцію, що становить серйозний ризик

Опубліковано 20.05.2016 о 00:00


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Urgent field safety notice for AutoSPECT Pro on Extended Brilliance Workspace NM software version 2.0, Royal Philips

Radiological technology – CT scanners

PDF95KB

Urgent Safety Notice for Users of e.cam and all Symbia systems with foresight detectors, Siemens Medical Solutions USA, Inc.

Radiological technology – equipment for nuclear medical functional and localisation diagnostics

PDF358KB

Updated Urgent Safety Notice for the Strattice Reconstructive Tissue Matrix, LifeCell Corporation

Non-active implants – special implants

PDF100KB

Lot recall of AO „2 in 1“ cannulated drill dia. 2.2/3.0 mm L. 32 mm – STERILE Reference: 159023S, Integra LifeSciences Services / Newdeal SAS

Medical instruments for use in humans – bone surgery

PDF236KB

Urgent field safety notice for Instinct Java System Instruments, all lot numbers / Universal Clamp System Instruments, all lot numbers / UniWallis System Instruments, all lot numbers , ZIMMER BIOMET

Medical instruments for use in humans – bone surgery

PDF275KB

Recall and updated instructions for use for Lifetech CeraFlex Atrial Septal Defect (ASD) Occluder, Lifetech Scientific (Shenzhen) Co. Ltd.

Non-active implants – cardiac surgery

PDF864KB

Urgent field safety notice for TJF-Q180V Duodenoscope, OLYMPUS

Optics / Precision engineering – endoscopes

PDF111KB

Urgent field safety notice for BD Retic-Count (IVD), Becton Dickinson S.A.S

In-vitro diagnostics – haematological, histological and cytological products

PDF108KB

Urgent field safety notice for VERSANT kPCR Molecular System, Siemens Healthcare Diagnostics Inc.

In-vitro diagnostics – instruments, apparatuses and systems

PDF38KB

Recall of WATCHMAN FLX Left Atrial Appendage (LAA) Closure Device, Boston Scientific International S.A.

Non-active implants – cardiac surgery

PDF42KB

Urgent field safety notice for G4 Platinum- and G5 Mobile Continuous Glucose Monitoring System, Dexcom

Medical electronics / Electromedical devices – electrodiagnostics

PDF258KB

Recall of all hand pieces for the VersaCut+ Tissue Morcellator, Lumenis Ltd.

Optics / Precision engineering – endoscopes

PDF188KB

Urgent field safety notice for Accu-Chek Insight system, Roche Diabetes Care

Injections / Infusions / Transfusions / Dialysis – infusion technology

PDF97KB

Lot recall of Fetch 2 Aspiration Catheter, Boston Scientific International S.A.

Injections / Infusions / Transfusions / Dialysis – infusion technology

PDF43KB

Urgent field safety notice for ELITE, Heavy Duty and Footed attachments, Stryker GmbH & Co. KG

Surgical equipment/ Anaesthesia – surgical equipment

PDF273KB

Recall of LIL’ ANGEL VEST, Össur

Non-active implants – bone surgery

PDF336KB

Recall of BIRMINGHAM HIP RESURFACING Extraction Kit (Instrument), Smith & Nephew Orthopaedics Ltd.

Medical instruments for use in humans – bone surgery

PDF71KB

Lot recall of Covidien Curity All Purpose Gauze Sponges / Curity X-Ray Detectable Laparotomy Sponges / Kerlix X-Ray Detectable Laparotomy Sponges and Vistec X-Ray Detectable Sponges, Medtronic

Dressings / Pads – swabs, sponges, wipes, swabsticks

PDF629KB

Urgent field safety notice for IONTRIS (10013850 und 10013851, Siemens AG), Siemens Healthcare GmbH

Radiotherapy / Radiation protection – nuclear medical therapeutic equipment

PDF199KB

Urgent field safety notice for SOMATOM FORCE with VA50A / VA50A_SP2 – kernel Hp38, Siemens Healthcare GmbH

Radiological technology – CT scanners

PDF497KB

Urgent field safety notice for AutoSPECT Pro on: IntelliSpace Portal software versions 5.0 / 6.0 / 7.0, Philips Healthcare

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

PDF34KB

Urgent Field Safety Notice for AQT90 FLEX Test Kit Boxes and CAL Cartridges, Radiometer

In-vitro diagnostics – immunological products

PDF23KB

Lot recall of KAMRA ACI 7000 Corneal Inlays, AcuFocus Inc.

Non-active implants – other implants

PDF82KB

Lot recall of CA090 Direct Drive Clip Appliers, Applied Medical

Medical instruments for use in humans – visceral surgery

PDF439KB

Urgent field safety notice for Aisys family of anesthesia devices, GE Healthcare

Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply

PDF162KB

Urgent Field Safety Notice for LABGEOPT Renal Test 6, Samsung Electronics

In-vitro diagnostics – equipment / products for clinical chemistry

PDF310KB

Urgent field safety notice for OXYWAY pressure reducer for Fast and Click types, WEINMANN Emergency Medical Technology GmbH & Co. KG

Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply

PDF70KB

Lot recall of Streptococcal Grouping Kit (DR0585A), Oxoid Limited

In-vitro diagnostics – microbiological products

PDF82KB

Urgent field safety notice for Pleural Drainage System, Teleflex Medical

Injections / Infusions / Transfusions / Dialysis – insulin pens and pen cannulas

PDF439KB

Urgent field safety notice for surgery gown, Wozabal MPZ Medizinproduktezentrum GmbH & Co. KG

Surgical equipment/ Anaesthesia – surgical equipment

PDF373KB

Urgent field safety notice for fT4-CTK Kit, DiaSorin S.p.A

In-vitro diagnostics – immunological products

PDF34KB

Urgent field safety notice for ARCHITECT Estradiol Reagent / list number (LN) 7K72, Abbott Diagnostics

In-vitro diagnostics – immunological products

PDF52KB

Urgent field safety notice for kits Simplexa HSV 1 & 2 Direct, Simplexa Flu A/B & RSV Direct and Simplexa Group A Strep Direct, Focus Diagnostics

In-vitro diagnostics – microbiological products

PDF100KB

Urgent field safety notice for ADVIA chemistry systems and Dimension clinical chemistry systems / Dimension Vista System, Siemens Healthcare Diagnostics Inc.

In-vitro diagnostics – equipment / products for clinical chemistry

PDF120KB

Urgent field safety notice for ADVIA 560 Hematology System, Siemens Healthcare Diagnostics GmbH

In-vitro diagnostics – equipment / products for clinical chemistry

PDF70KB

Lot recall of CELL-DYN Emerald Cleaner, Abbott Laboratories

In-vitro diagnostics – microbiological products

PDF43KB

Urgent field safety notice for Uni-Gold LUA Plus, Trinity Biotech

In-vitro diagnostics – equipment / products for clinical chemistry

PDF1MB

Lot recall of ROTEM platelet cuvettes, Tem Innovations GmbH

In-vitro diagnostics – instruments, apparatuses and systems

PDF372KB

Urgent field safety notice for Dimension Vista 500 and 1500 Intelligent Lab System, Siemens Healthcare Diagnostics Inc.

In-vitro diagnostics – equipment / products for clinical chemistry

PDF158KB

Urgent field safety notice for hypo- / hyperthermia units, Xenios AG

Surgical equipment/ Anaesthesia – surgical equipment

PDF278KB

Urgent field safety notice for Da Vinci S / Si / Xi Surgical Systems, INTUITIVE SURGICAL

Surgical equipment/ Anaesthesia – surgical equipment

PDF126KB

Batch recall of Stainless steel head Ø22 Medium Neck, Evolutis

Non-active implants – bone surgery

PDF283KB

Urgent field safety notice for CDI Blood Parameter Monitoring System 500 / BPM Sensor Head Assembly, TERUMO Europe NV

Surgical equipment/ Anaesthesia – surgical equipment

PDF265KB

Urgent field safety information for Universal arm support, TRUMPF Medizin Systeme GmbH + Co. KG

Surgical equipment/ Anaesthesia – surgical equipment

PDF156KB

Urgent field safety notice for ABX PENTRA 400 (version 5.0.8 or lower) and PENTRA C400 (version 1.1.2 or lower), HORIBA ABX SAS

In-vitro diagnostics – equipment / products for clinical chemistry

PDF414KB

Urgent field safety notice for ThinPrep 5000 Processor with Autoloader, Hologic Inc.

In-vitro diagnostics – haematological, histological and cytological products

PDF78KB

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

In-vitro diagnostics – equipment / products for clinical chemistry

PDF141KB

Urgent field safety notice for Leksell Gamma Knife Perfexion and Leksell Gamma Knife Icon, Elekta Instrument AB

Radiotherapy / Radiation protection – radiotherapy treatment planning systems

PDF85KB

Urgent Field Safety Notice for Protura Robotic Patient Positioning Software, CIVCO Medical Solutions

Radiotherapy / Radiation protection – radiation facilites with accelerators for teletherapy

PDF262KB

Urgent field safety notice for ADVIA Centaur CP, Siemens Healthcare Diagnostics Inc.

In-vitro diagnostics – equipment / products for clinical chemistry

PDF79KB

Urgent field safety notice for Duraloc Option LPW Poly Inserts, DePuy Synthes

Non-active implants – bone surgery

PDF137KB

Urgent field safety notice for StimaWELL 120MTRS (Art.-Nr.200199-G), PIERENKEMPER GmbH

Medical electronics / Electromedical devices – electrotherapy

PDF814KB

Lot recall of Medex Cardiothoracic Custom Sets, Smiths Medical International Ltd.

Injections / Infusions / Transfusions / Dialysis – catheters

PDF273KB

Lot recall of Cell Saver Elite disposable processing kits ref. CSE-P-225, HAEMONETICS S.A.

Injections / Infusions / Transfusions / Dialysis – transfusion kits

PDF187KB

Urgent field safety notice for Digitoxin Reagent, Roche Diagnostics

In-vitro diagnostics – equipment / products for clinical chemistry

PDF147KB

Urgent Field Safety Notice for Algovita Spinal Cord System Stimulators Implantable (IPG) and External / Trial (EPG), Algostim LLC

Active implantable medical devices – biostimulators

PDF371KB

Recall of PENTARAY catheters, Johnson & Johnson Medical NV/SA / Biosense Webster

Injections / Infusions / Transfusions / Dialysis – catheters

PDF300KB

Urgent field safety notice for 360 TIBIAL AUGMENT, Biomet UK Ltd. / Zimmer Biomet

Non-active implants – bone surgery

PDF136KB

Urgent field safety notice for Etermis 2, Merz Pharmaceuticals GmbH

Non-active implants – materials for implants

PDF66KB

Urgent field safety notice for Analyst MD Software, SCIEX

In-vitro diagnostics – instruments, apparatuses and systems

PDF281KB

Urgent field safety notice for iChemVELOCITY Automated Urine Chemistry System using iChemVELOCITY Urine Chemistry Strips, Iris International / Beckman Coulter

In-vitro diagnostics – equipment / products for clinical chemistry

PDF108KB

Urgent field safety notice for SagiNova Control Software, Eckert & Ziegler BEBIG GmbH

Radiotherapy / Radiation protection – nuclear medical therapeutic equipment

PDF166KB

Urgent field safety notice for Biolox Delta Ceramic Head 32mm, Biomet UK Ltd.

Non-active implants – bone surgery

PDF275KB

Urgent field safety notice for M2a 38mm Acetabular System, ZIMMER BIOMET

Non-active implants – bone surgery

PDF178KB

Urgent field safety notice for 21inch monitor arm for ARIETTA 60 and ARIETTA 70, Hitachi Ltd.

Ultrasonics – ultrasonic diagnostic equipment

PDF158KB

Urgent field safety notice for cobas EGFR Mutation Test v2 CE-IVD, Roche Diagnostics

In-vitro diagnostics – immunological products

PDF146KB

Urgent Field Safety Notice for A.V. Fistula Sets for Hemodialysis, KAWASUMI LABORATORIES INC. / Asahi Kasei Medical Europe GmbH

Injections / Infusions / Transfusions / Dialysis – injection kits

PDF194KB

Lot recall for Trilly Oxygenator, EUROSETS s.r.l.

Surgical equipment/ Anaesthesia – surgical equipment

PDF388KB

Urgent field safety notice for On-Board Imager with CBCT, Varian Medical Systems

Radiotherapy / Radiation protection – radiotherapy treatment planning systems

PDF71KB

Urgent Field Safety Notice for Image Suite 3.0 with Mini-PACS Options and Hot Fix 3004 software patch / Image Suite 4.0 with Mini-PACS and DICOM Store, Carestream Health

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

PDF28KB

Urgent field safety notice for Discovery IGS 730 and Discovery IGS 740 systems, GE Healthcare

Radiological technology – stationary radiological equipment

PDF102KB

Urgent field safety notice for Digitoxin OSR6403, Beckman Coulter Inc.

In-vitro diagnostics – equipment / products for clinical chemistry

PDF225KB

Lot recall for ID-Papain, Bio-Rad / DiaMed GmbH

In-vitro diagnostics – haematological, histological and cytological products

PDF304KB

Urgent Field Safety Notice for IMMULITE / IMMULITE 1000, Siemens Healthcare Diagnostics Inc.

In-vitro diagnostics – immunological products

PDF48KB

Urgent Field Safety Notice for Hemochron Microcoagulation System APTT Test Cuvettes, Accriva Diagnostic

In-vitro diagnostics – haematological, histological and cytological products

PDF244KB

Urgent field safety notice for VITROS 3600 and VITROS 5600 Systems, Ortho-Clinical Diagnostics GmbH

In-vitro diagnostics – equipment / products for clinical chemistry

PDF1MB

Lot recall of various sports medicine and trauma products, ZIMMER BIOMET

Non-active implants – bone surgery

PDF383KB

Urgent field safety notice for Lotus™ Valve System, Boston Scientific International S.A.

Non-active implants – cardiac surgery

PDF70KB

Urgent field safety notice for EPIQ Ultrasound System, Philips Ultrasound

Ultrasonics – ultrasonic diagnostic equipment

PDF33KB

Recall of Zelos PTA-balloon catheter, optimed GmbH

Injections / Infusions / Transfusions / Dialysis – catheters

PDF179KB

Urgent field safety notice for G5 and S1 ventilators, Hamilton Medical AG

Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply

PDF179KB

 

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