Людям із порушенням зору 
In English 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
http://www.bfarm.de/SiteGlobals/Forms/Suche/EN/kundeninfo_Filtersuche_Formular_en.html?nn=4527724
Urgent field safety notice for AutoSPECT Pro on Extended Brilliance Workspace NM software version 2.0, Royal Philips
Radiological technology – CT scanners
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
Updated Urgent Safety Notice for the Strattice Reconstructive Tissue Matrix, LifeCell Corporation
Non-active implants – special implants
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
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
Recall and updated instructions for use for Lifetech CeraFlex Atrial Septal Defect (ASD) Occluder, Lifetech Scientific (Shenzhen) Co. Ltd.
Non-active implants – cardiac surgery
Urgent field safety notice for TJF-Q180V Duodenoscope, OLYMPUS
Optics / Precision engineering – endoscopes
Urgent field safety notice for BD Retic-Count (IVD), Becton Dickinson S.A.S
In-vitro diagnostics – haematological, histological and cytological products
Urgent field safety notice for VERSANT kPCR Molecular System, Siemens Healthcare Diagnostics Inc.
In-vitro diagnostics – instruments, apparatuses and systems
Recall of WATCHMAN FLX Left Atrial Appendage (LAA) Closure Device, Boston Scientific International S.A.
Non-active implants – cardiac surgery
Urgent field safety notice for G4 Platinum- and G5 Mobile Continuous Glucose Monitoring System, Dexcom
Medical electronics / Electromedical devices – electrodiagnostics
Recall of all hand pieces for the VersaCut+ Tissue Morcellator, Lumenis Ltd.
Optics / Precision engineering – endoscopes
Urgent field safety notice for Accu-Chek Insight system, Roche Diabetes Care
Injections / Infusions / Transfusions / Dialysis – infusion technology
Lot recall of Fetch 2 Aspiration Catheter, Boston Scientific International S.A.
Injections / Infusions / Transfusions / Dialysis – infusion technology
Urgent field safety notice for ELITE, Heavy Duty and Footed attachments, Stryker GmbH & Co. KG
Surgical equipment/ Anaesthesia – surgical equipment
Recall of LIL’ ANGEL VEST, Össur
Non-active implants – bone surgery
Recall of BIRMINGHAM HIP RESURFACING Extraction Kit (Instrument), Smith & Nephew Orthopaedics Ltd.
Medical instruments for use in humans – bone surgery
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
Urgent field safety notice for IONTRIS (10013850 und 10013851, Siemens AG), Siemens Healthcare GmbH
Radiotherapy / Radiation protection – nuclear medical therapeutic equipment
Urgent field safety notice for SOMATOM FORCE with VA50A / VA50A_SP2 – kernel Hp38, Siemens Healthcare GmbH
Radiological technology – CT scanners
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
Urgent Field Safety Notice for AQT90 FLEX Test Kit Boxes and CAL Cartridges, Radiometer
In-vitro diagnostics – immunological products
Lot recall of KAMRA ACI 7000 Corneal Inlays, AcuFocus Inc.
Non-active implants – other implants
Lot recall of CA090 Direct Drive Clip Appliers, Applied Medical
Medical instruments for use in humans – visceral surgery
Urgent field safety notice for Aisys family of anesthesia devices, GE Healthcare
Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply
Urgent Field Safety Notice for LABGEOPT Renal Test 6, Samsung Electronics
In-vitro diagnostics – equipment / products for clinical chemistry
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
Lot recall of Streptococcal Grouping Kit (DR0585A), Oxoid Limited
In-vitro diagnostics – microbiological products
Urgent field safety notice for Pleural Drainage System, Teleflex Medical
Injections / Infusions / Transfusions / Dialysis – insulin pens and pen cannulas
Urgent field safety notice for surgery gown, Wozabal MPZ Medizinproduktezentrum GmbH & Co. KG
Surgical equipment/ Anaesthesia – surgical equipment
Urgent field safety notice for fT4-CTK Kit, DiaSorin S.p.A
In-vitro diagnostics – immunological products
Urgent field safety notice for ARCHITECT Estradiol Reagent / list number (LN) 7K72, Abbott Diagnostics
In-vitro diagnostics – immunological products
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
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
Urgent field safety notice for ADVIA 560 Hematology System, Siemens Healthcare Diagnostics GmbH
In-vitro diagnostics – equipment / products for clinical chemistry
Lot recall of CELL-DYN Emerald Cleaner, Abbott Laboratories
In-vitro diagnostics – microbiological products
Urgent field safety notice for Uni-Gold LUA Plus, Trinity Biotech
In-vitro diagnostics – equipment / products for clinical chemistry
Lot recall of ROTEM platelet cuvettes, Tem Innovations GmbH
In-vitro diagnostics – instruments, apparatuses and systems
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
Urgent field safety notice for hypo- / hyperthermia units, Xenios AG
Surgical equipment/ Anaesthesia – surgical equipment
Urgent field safety notice for Da Vinci S / Si / Xi Surgical Systems, INTUITIVE SURGICAL
Surgical equipment/ Anaesthesia – surgical equipment
Batch recall of Stainless steel head Ø22 Medium Neck, Evolutis
Non-active implants – bone surgery
Urgent field safety notice for CDI Blood Parameter Monitoring System 500 / BPM Sensor Head Assembly, TERUMO Europe NV
Surgical equipment/ Anaesthesia – surgical equipment
Urgent field safety information for Universal arm support, TRUMPF Medizin Systeme GmbH + Co. KG
Surgical equipment/ Anaesthesia – surgical equipment
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
Urgent field safety notice for ThinPrep 5000 Processor with Autoloader, Hologic Inc.
In-vitro diagnostics – haematological, histological and cytological products
Urgent field safety notice for oneHbA1c IS INNOVASTAR, DiaSys Diagnostic Systems GmbH
In-vitro diagnostics – equipment / products for clinical chemistry
Urgent field safety notice for Leksell Gamma Knife Perfexion and Leksell Gamma Knife Icon, Elekta Instrument AB
Radiotherapy / Radiation protection – radiotherapy treatment planning systems
Urgent Field Safety Notice for Protura Robotic Patient Positioning Software, CIVCO Medical Solutions
Radiotherapy / Radiation protection – radiation facilites with accelerators for teletherapy
Urgent field safety notice for ADVIA Centaur CP, Siemens Healthcare Diagnostics Inc.
In-vitro diagnostics – equipment / products for clinical chemistry
Urgent field safety notice for Duraloc Option LPW Poly Inserts, DePuy Synthes
Non-active implants – bone surgery
Urgent field safety notice for StimaWELL 120MTRS (Art.-Nr.200199-G), PIERENKEMPER GmbH
Medical electronics / Electromedical devices – electrotherapy
Lot recall of Medex Cardiothoracic Custom Sets, Smiths Medical International Ltd.
Injections / Infusions / Transfusions / Dialysis – catheters
Lot recall of Cell Saver Elite disposable processing kits ref. CSE-P-225, HAEMONETICS S.A.
Injections / Infusions / Transfusions / Dialysis – transfusion kits
Urgent field safety notice for Digitoxin Reagent, Roche Diagnostics
In-vitro diagnostics – equipment / products for clinical chemistry
Urgent Field Safety Notice for Algovita Spinal Cord System Stimulators Implantable (IPG) and External / Trial (EPG), Algostim LLC
Active implantable medical devices – biostimulators
Recall of PENTARAY catheters, Johnson & Johnson Medical NV/SA / Biosense Webster
Injections / Infusions / Transfusions / Dialysis – catheters
Urgent field safety notice for 360 TIBIAL AUGMENT, Biomet UK Ltd. / Zimmer Biomet
Non-active implants – bone surgery
Urgent field safety notice for Etermis 2, Merz Pharmaceuticals GmbH
Non-active implants – materials for implants
Urgent field safety notice for Analyst MD Software, SCIEX
In-vitro diagnostics – instruments, apparatuses and systems
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
Urgent field safety notice for SagiNova Control Software, Eckert & Ziegler BEBIG GmbH
Radiotherapy / Radiation protection – nuclear medical therapeutic equipment
Urgent field safety notice for Biolox Delta Ceramic Head 32mm, Biomet UK Ltd.
Non-active implants – bone surgery
Urgent field safety notice for M2a 38mm Acetabular System, ZIMMER BIOMET
Non-active implants – bone surgery
Urgent field safety notice for 21inch monitor arm for ARIETTA 60 and ARIETTA 70, Hitachi Ltd.
Ultrasonics – ultrasonic diagnostic equipment
Urgent field safety notice for cobas EGFR Mutation Test v2 CE-IVD, Roche Diagnostics
In-vitro diagnostics – immunological products
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
Lot recall for Trilly Oxygenator, EUROSETS s.r.l.
Surgical equipment/ Anaesthesia – surgical equipment
Urgent field safety notice for On-Board Imager with CBCT, Varian Medical Systems
Radiotherapy / Radiation protection – radiotherapy treatment planning systems
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
Urgent field safety notice for Discovery IGS 730 and Discovery IGS 740 systems, GE Healthcare
Radiological technology – stationary radiological equipment
Urgent field safety notice for Digitoxin OSR6403, Beckman Coulter Inc.
In-vitro diagnostics – equipment / products for clinical chemistry
Lot recall for ID-Papain, Bio-Rad / DiaMed GmbH
In-vitro diagnostics – haematological, histological and cytological products
Urgent Field Safety Notice for IMMULITE / IMMULITE 1000, Siemens Healthcare Diagnostics Inc.
In-vitro diagnostics – immunological products
Urgent Field Safety Notice for Hemochron Microcoagulation System APTT Test Cuvettes, Accriva Diagnostic
In-vitro diagnostics – haematological, histological and cytological products
Urgent field safety notice for VITROS 3600 and VITROS 5600 Systems, Ortho-Clinical Diagnostics GmbH
In-vitro diagnostics – equipment / products for clinical chemistry
Lot recall of various sports medicine and trauma products, ZIMMER BIOMET
Non-active implants – bone surgery
Urgent field safety notice for Lotus™ Valve System, Boston Scientific International S.A.
Non-active implants – cardiac surgery
Urgent field safety notice for EPIQ Ultrasound System, Philips Ultrasound
Ultrasonics – ultrasonic diagnostic equipment
Recall of Zelos PTA-balloon catheter, optimed GmbH
Injections / Infusions / Transfusions / Dialysis – catheters
Urgent field safety notice for G5 and S1 ventilators, Hamilton Medical AG
Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply
If you have found a spelling error, please, notify us by selecting that text and pressing Ctrl+Enter.
