Аналіз інформації за період 01.08.2016 – 31.08.2016, отриманої з іноземних систем повідомлення про продукцію, що становить серйозний ризик

Опубліковано 02.09.2016 о 00:00


Німеччина

http://www.bfarm.de/SiteGlobals/Forms/Suche/EN/kundeninfo_Filtersuche_Formular_en.html?nn=4527724

 

Lot recall of specific EndoWrist® Stapler 45 and 30 instruments for the da Vinci® Xi™ Surgical System, Intuitive Surgical, Inc.

Surgical equipment/ Anaesthesia – surgical equipment

PDF613KB

Lot recall of RUSCH – TracheoFlex Tracheostomie Tubes, Teleflex Medical

Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply

PDF405KB

Urgent field safety notice for SeronormPaediatric, SERO AS

In-vitro diagnostics – equipment / products for clinical chemistry

PDF2MB

Urgent field safey notice for Flocare Infinity enteral feeding pump, Nutricia Devices BV

Injections / Infusions / Transfusions / Dialysis – infusion technology

PDF181KB

Urgent field safety notice for Astral – Managing Degraded Battery Pack and Battery Update, ResMed Ltd.

Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply

PDF356KB

Lot recall of Edwards Commander Delivery System Models 9610TF23 / 9610TF26 / 9610TF29, Edwards Lifesciences

Injections / Infusions / Transfusions / Dialysis – catheters

PDF65KB

Lot recall of Heliosphere Newtech, Helioscopie Medical Implants / M + C Medizingeräte Chirurgiebedarf Vertriebs GmbH

Non-active implants – special implants

PDF310KB

Urgent field safety notice for ProCarve Knee Joint and Foot, Otto Bock HealthCare GmbH

Orthopaedic / Rehabilitation technology – prostheses (exoprostheses)

PDF255KB

Recall of Hip-med, Thuasne Deutschland GmbH

Orthopaedic / Rehabilitation technology – orthoses

PDF161KB

Urgent field safety notice for APM 440X, Novacare GmbH

General equipment for medical treatment – furnishings

PDF313KB

Urgent field safety notice for neoBLUE LED Phototherapy System, Natus Medical Incorporated

Physical therapy – phototherapy

PDF165KB

Lot recall of Trident Universal Impactor / Positioner, Stryker Orthopaedics

Medical instruments for use in humans – bone surgery

Lot recall of QMS Everolimus Immunoassay, Thermo Fisher Scientific / Microgenics Corporation

In-vitro diagnostics – equipment / products for clinical chemistry

PDF342KB

Urgent field safety notice for Anaplasma phagocytophilum IFA IgM Kit (IF1450M), Focus Diagnostics Inc.

In-vitro diagnostics – microbiological products

PDF83KB

Urgent field safety notice for iGUIDE / HexaPOD, Elekta AB / Medical Intelligence Medizintechnik GmbH

Surgical equipment/ Anaesthesia – surgical equipment

PDF34KB

Urgent field safety notice for Eye Care PACS and Eye Station, Merge Healthcare

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

PDF131KB

Lot recall of NIO-A, WaisMed Ltd.

Injections / Infusions / Transfusions / Dialysis – syringes and cannulas

PDF261KB

Urgent field safety notice for Perceval Sutureless Heart Valve, Sorin Group Italia S.r.l. / LivaNova Canada Corp.

Non-active implants – cardiac surgery

PDF1MB

Urgent field safety notice for LIAISON Estradiol II Gen, DiaSorin Inc. US

In-vitro diagnostics – immunological products

PDF389KB

Urgent field safety notice for TANGO infinity, Bio-Rad Medical Diagnostics GmbH

In-vitro diagnostics – instruments, apparatuses and systems

PDF258KB

Urgent field safety notice for UniCel DxH 600 / 800 Cellular Analysis System, Beckman Coulter

In-vitro diagnostics – haematological, histological and cytological products

PDF73KB

Lot recall of OSSEOTITE Certain Implant 4 x 11.5 mm (IOSS411), Zimmer Biomet / Biomet 3i

Dental products – dental implants

PDF300KB

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

Surgical equipment/ Anaesthesia – surgical equipment

PDF135KB

Lot recall of Roadrunner UniGlide hydrophilic wire guide, Cook Medical Europe

Injections / Infusions / Transfusions / Dialysis – catheters

PDF48KB

Lot recall of Triglyceride concentrated (TRIG_c) reagent, Siemens Healthcare Diagnostics Inc.

In-vitro diagnostics – equipment / products for clinical chemistry

PDF30KB

Lot recall of sanabelle I800 PEG/SPK bandage set or Freka bandage set SPK/PEG, medi1one medical GmbH

Dressings / Pads – dressings

PDF190KB

Urgent field safety notice for BCS / BCS XP – INNOVANCE ETP, Siemens Healthcare Diagnostics Products GmbH

In-vitro diagnostics – haematological, histological and cytological products

PDF405KB

Lot recall of OPTILENE 4/0 (1,5) 90 CM 2XHRC22, B. Braun Surgical S.A.

Dressings / Pads – surgical sutures, vascular loops etc.

PDF136KB

Recall of HVAD pumps, HeartWare

Active implantable medical devices – artificial hearts

PDF417KB

Urgent field safety notice for Dimension Vista System Calcium Flex reagent cartridge, Siemens Healthcare Diagnostics Inc.

In-vitro diagnostics – equipment / products for clinical chemistry

PDF27KB

Urgent field safety notice for Monaco, Elekta / IMPAC Medical Systems Inc.

Radiotherapy / Radiation protection – radiotherapy treatment planning systems

PDF54KB

Urgent field safety notice for AP Cutting Block Triathlon / Scorpio, Stryker / Spierings Orthopaedics B.V.

Medical instruments for use in humans – bone surgery

PDF255KB

Recall of Shoulder Forked Retractor, Zimmer Biomet

Medical instruments for use in humans – bone surgery

PDF99KB

Urgent field safety notice for IntelliVue Patient Monitors MX400 / MX430 / MX450 / MX500 / MX550, Philips Healthcare

Medical electronics / Electromedical devices – electrodiagnostics

PDF122KB

Lot recall of 1.5 mm Hydro Valvulotome, LeMaitre Vascular GmbH

Medical instruments for use in humans – cardiac/thorax surgery

PDF627KB

Lot recall of Angel Blood Access Kit, Citra Labs / Nuo Therapeutics (Cytomedix Inc.) / Arthrex GmbH

Injections / Infusions / Transfusions / Dialysis – syringes and cannulas

PDF171KB

Lot / batch recall of Dynesys pedicle Screw + Set Screw 6.0×35, Zimmer Biomet / Zimmer GmbH

Non-active implants – bone surgery

PDF262KB

Recall of MISAGO selfexpanding stent system, Terumo Europe NV

Non-active implants – special implants

PDF205KB

Lot recall of Scorpio Patella Assembly Instrument, Stryker Orthopaedics

Medical instruments for use in humans – bone surgery

PDF131KB

Lot recall of Bardex 3 Way Male 30 cc / 50 cc Preshaped Ribbed Sac Lubricious Coated Catheter, C. R. Bard Inc. / Bard Limited

Injections / Infusions / Transfusions / Dialysis – catheters

PDF35KB

Urgent field safety notice for e.cam and Symbia E systems, Siemens Medical Solutions USA Inc.

Radiological technology – equipment for nuclear medical functional and localisation diagnostics

PDF7MB

Urgent Field Safety Notice for DICOM Importer Pro, medavis GmbH

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

PDF213KB

Lot recall of S100A1 (EP184) Rabbit Monoclonal Antibody, Cell Marque / Medac GmbH

In-vitro diagnostics – haematological, histological and cytological products

PDF265KB

Urgent field safety notice for DxH 500 (PN B40601), Beckman Coulter

In-vitro diagnostics – haematological, histological and cytological products

PDF73KB

Urgent field safety notice for ADVIA Chemistry XPT Systems, Siemens Healthcare Diagnostics Inc.

In-vitro diagnostics – equipment / products for clinical chemistry

PDF45KB

Urgent field safety notice for Mueller Hinton 2 agar + 5 % sheep blood (Ref. 43321 / 43329 / 43324), bioMérieux SA

In-vitro diagnostics – microbiological products

PDF277KB

Urgent field safety notice for UniCel DxH Slidemaker Stainer Cellular Analysis System, Beckman Coulter

In-vitro diagnostics – haematological, histological and cytological products

PDF75KB

Urgent field safety notice for Xprecia Stride Coagulation Analyzer, Siemens Healthcare Diagnostics Inc.

In-vitro diagnostics – haematological, histological and cytological products

PDF59KB

Urgent field safety notice for Afinion CRP, Alere Technologies AS

In-vitro diagnostics – immunological products

PDF117KB

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

In-vitro diagnostics – immunological products

PDF74KB

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

In-vitro diagnostics – equipment / products for clinical chemistry

PDF173KB

Lot recall of Metalline products with metal needles, Lohmann & Rauscher GmbH & Co. KG

Dressings / Pads – dressings

PDF61KB

Urgent field safety notice for Puritan Bennett 980 Series Ventilator System, Covidien Deutschland GmbH

Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply

PDF85KB

Urgent field safety notice for ProcedurePak kits and trays containing umbilical clamps (IFKR21 & 2305123-00), Mölnlycke Health Care

Medical instruments for use in humans – gynaecology

PDF109KB

Urgent medical device correction for LIFEPAK CR ® Plus AED and LIFEPAK EXPRESS ® AED, Physio Control UK Sales Ltd.

Medical electronics / Electromedical devices – electrotherapy

PDF132KB

Urgent field safety notice for the modification of the gantry base drive wheel assembly Precise series Linac / Product: Digital Accelerator, Elekta Ltd.

Radiotherapy / Radiation protection – radiation facilites with accelerators for teletherapy

PDF81KB

Urgent field safety notice for BK Virus R-gene ® Real-time Detection an Quantification Kit (ref 69-013B), bioMerieux SA

In-vitro diagnostics – microbiological products

PDF291

Urgent field safety notice for Etest ® Colistin CO256 WW (Ref. 537300 / 537308), BioMerieux SA

In-vitro diagnostics – microbiological products

PDF306KB

Urgent field safety notice for EnVeo R Delivery Catheter System, Medtronic

Injections / Infusions / Transfusions / Dialysis – catheters

PDF56KB

Lot recall of Sinaqua Dermal Glove / Sinaqua Wipe / Easyderm Glove, Welcare lndustries S.p.A. / medi GmbH & Co. KG

General equipment for medical treatment – cleaning / disinfection / sterilisation

PDF302KB

Lot recall of blood donor set 4-BB-SK-100-E, Fresenius Kabi Deutschland GmbH

Injections / Infusions / Transfusions / Dialysis – equipment for collecting blood products and peripheral stem cells

PDF160KB

Urgent field safety notice for dynamic seat shell system with undercarriage AKTIVLINE, interco GmbH

Orthopaedic / Rehabilitation technology – mobility aids

PDF43KB

Urgent field safety notice for G-scan Brio Magnetic Resonance System, Esaote

Electromedical fields – equipment for MR tomography

PDF328KB

Urgent field safety notice for MylabTwice, Esaote

Ultrasonics – ultrasonic diagnostic equipment

PDF184KB

Urgent field safety notice for CADstream versions earlier than 5.2.6, Merge Healthcare

Medical data processing (software) – software for MR tomography

PDF121KB

Urgent field safety notice for CADstream, Merge Healthcare

Medical data processing (software) – software for MR tomography

PDF122KB

Batch recall of Hermann Gastrostomy Dressing Set, Fresenius Kabi AG

Dressings / Pads – dressings

PDF27KB

Urgent field safety notice for Silver Tracheostomy Tubes, Phoenix Surgical lnstruments

Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply

PDF547KB

Urgent field safety notice for syngo RT Oncologist, Siemens Healthcare GmbH

Radiotherapy / Radiation protection – radiotherapy treatment planning systems

PDF25KB

Lot recall of Sterile RENASYS Transparent Film, Smith & Nephew Inc.

Dressings / Pads – dressings

PDF428KB

Urgent field safety notice for sterile Introducer Needle 18G, Kimal plc

Injections / Infusions / Transfusions / Dialysis – syringes and cannulas

PDF287KB

Urgent field safety notice for Eye Station and Eye Care PACS, Merge Healthcare

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

PDF132KB

Urgent field safety notice for syngo RT Therapist, Siemens Healthcare GmbH

Radiotherapy / Radiation protection – radiotherapy treatment planning systems

PDF39KB

Lot recall of mini²SKY gingiva former, bredent medical GmbH & Co. KG

Dental products – dental implants

PDF197KB

Lot recall of Lotus Valve System, Boston Scientific International S.A.

Non-active implants – cardiac surgery

PDF143KB

Urgent Field Safety Notice for patient table (Ysio / Ysio Max / Multix Fusion), Siemens Healthcare GmbH

Radiological technology – stationary radiological equipment

PDF256KB

Urgent field safety notice for Laerdal Suction Unit (LSU) with LSU NiMH Battery, Laerdal Medical AS

Surgical equipment/ Anaesthesia – surgical equipment

PDF371KB

Urgent field safety notice for TrueBeam Radiotherapy Delivery System with AlignRT, Varian Medical Systems

Radiotherapy / Radiation protection – radiation facilites with accelerators for teletherapy

PDF94KB

 

Якщо ви знайшли помилку, будь ласка, виділіть фрагмент тексту та натисніть Ctrl+Enter.

Print button Версія для друку