Аналіз інформації за період 01.10.2015 – 31.10.2015 отриманої з іноземних систем повідомлення про продукцію, що становить серйозний ризик

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·                     2015.10.23 Urgent Field Safety Notice for EndoBarrier Gastrointestinal Liner System, GI Dynamics

Non-active implants – special implants PDF27KB

 

·                     2015.10.21 Safety Notice for the product Aquilion, Toshiba Medical Systems Corporation

Radiological technology – CT scanners PDF245KB

 

·                     2015.10.19 Corrective action for the Pak12, Immucor GTI Diagnostics

In-vitro diagnostics – microbiological products PDF105KB

 

·                     2015.10.19 Corrective action for the seleXys TH+ and seleXys TPS shells, Mathys Ltd. Bettlach

Non-active implants – bone surgery PDF61KB

 

·                     2015.10.19 Urgent Safety Notice for the Multigent Ammonia Ultra Reagent, Sentinel CH. Spa

In-vitro diagnostics – immunological products PDF2MB

 

·                     2015.10.19 Safety Corrective action for the femoral neck component, MicroPort Orthopedics

Non-active implants – bone surgery PDF383KB

 

·                     2015.10.19 Recall for the RotaWire Elite™ Guidewire and wireClip™ Torquer Guidewire Manipulation Device, Boston Scientific International S.A.

Injections / Infusions / Transfusions / Dialysis – catheters PDF317KB

 

·                     2015.10.19 Urgent Safety Notice for TheraSphere®-Y-90 Glass Microspheres, Biocompatibles UK Ltd. (BTG),

Active implantable medical devices – implantats emitting radioactive radiation PDF1MB

 

·                     2015.10.19 Urgent Safety Notice RAPIDPoint® 500 System, Siemens Healthcare Diagnostics Inc.

In-vitro diagnostics – equipment / products for clinical chemistry PDF73KB

 

·                     2015.10.16 Urgent field safety notice concerning testicular implant and vaginal stent – inflatable, Coloplast A/S

Non-active implants – special implants PDF206KB

 

·                     2015.10.15 Corrective action for the MetaVision® Suite, Clinical Information System – version 5.47, iMDsoft

Medical data processing (software) – others PDF408KB

 

·                     2015.10.15 Recall for Endotracheal tubes, Vygon

Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply PDF151KB

 

·                     2015.10.15 Corrective action for Tests based on trinder reactions, Thermo Fisher Scientific Oy

In-vitro diagnostics – equipment / products for clinical chemistry PDF3MB

 

·                     2015.10.15 Corrective action involving the P3 Medical Vented Tracheal Tube Guides (Bougies), P3 Medical Limited

Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply PDF85KB

 

·                     2015.10.15 Corrective action for the ARCHITECT i2000SR System, Abbott

In-vitro diagnostics – instruments, apparatuses and systems PDF2MB

 

·                     2015.10.15 Urgent Safety Notice for the Neuro Omega system, Alpha Omega Engineering Ltd.

Radiotherapy / Radiation protection – radiotherapy treatment planning systems PDF290KB

 

·                     2015.10.15 Safety Notice for the Arrow® Pressure Injectable Peripherally Inserted Central Catheter (PICC) – 4FR, Arrow International, Inc.

Injections / Infusions / Transfusions / Dialysis – catheters PDF137KB

 

·                     2015.10.15 Recall for specific lots of LFIT V40 Tapers, V40 Tapers and PCA Tapers Vitallium Femoral Heads, STRYKER® ORTHOPAEDICS

Non-active implants – bone surgery PDF69KB

 

·                     2015.10.15 Safety Notice for the Allura Xper FD Systems, Philips Healthcare

Radiological technology – radiological equipment for vascular diagnostics PDF373KB

 

·                     2015.10.15 Safety Notice for the RSP Monoblock Fixture, Encore Medical dba DJO Surgical LLC

Medical instruments for use in humans – bone surgery PDF688KB

 

·                     2015.10.14 Corrective action for the Enteral Syringe Pumps P500, P700 and P900, Medicina Ltd.

Injections / Infusions / Transfusions / Dialysis – infusion technology PDF303KB

 

·                     2015.10.14 Safety Notice for the BD Plastipak Syringes / BD Oral Syringes, Becton Dickinson GmbH

Injections / Infusions / Transfusions / Dialysis – syringes and cannulas PDF305KB

 

·                     2015.10.14 Recall for MOSAICPLASTY™ Kits (MOSAICPLASTY DP – Disposable Harvesting System), Smith & Nephew, Inc.

Medical instruments for use in humans – bone surgery PDF103KB

 

·                     2015.10.14 Corrective action for the Brainlab iMRI Registration Matrix for GE, Brainlab AG

Radiological technology – navigation systems PDF693KB

 

·                     2015.10.14 Recall for Brainlab Disposable Reflective Marker Spheres (DRMS), Brainlab AG

Medical instruments for use in humans – special surgical instruments PDF445KB

 

·                     2015.10.14 Recall for the Laryngeal Suction Tube with Soft Tip, Pennine Healthcare

Surgical equipment/ Anaesthesia – surgical equipment PDF1MB

 

·                     2015.10.14 Safety Notice for Völker nursing beds, Völker GmbH

General equipment for medical treatment – furnishings PDF201KB

 

·                     2015.10.14 Safety Notice for the Philips Allura Xper FD, Philips Healthcare

Radiological technology – radiological equipment for vascular diagnostics PDF107KB

 

·                     2015.10.13 Urgent Field Safety Notice for ADVIA®Chemistry Systems, Alkaline Phosphatase, Siemens Healthcare Diagnostics

In-vitro diagnostics – equipment / products for clinical chemistry PDF41KB

 

·                     2015.10.13 Urgent Field Safetv Notice for LIAISON® Cortisol, DiaSorin

In-vitro diagnostics – equipment / products for clinical chemistry PDF2MB

 

·                     2015.10.13 Field Safety Notice for users of the MODULARIS Variastar, Siemens Healthcare GmbH

Ultrasonics – ultrasonic therapeutic equipment PDF1MB

 

·                     2015.10.13 Updated Instructions for Use for the Navigated Solera Screwdrivers, Medtronic

Medical instruments for use in humans – bone surgery PDF254KB

 

·                     2015.10.13 Urgent Field Safety Notice for Dimension Vista® Systems
Magnesium Flex® reagent cartridge, Siemens Healthcare Diagnostics Inc.

In-vitro diagnostics – equipment / products for clinical chemistry PDF127KB

 

·                     2015.10.13 Urgent Field Safety Notice for Smooth Muscle Actin (SMA), Biocare Medical

In-vitro diagnostics – instruments, apparatuses and systems PDF70KB

 

·                     2015.10.13 Advisory Field Safety Notice for Male / Female Shifting Top Housing, Blatchford Products Ltd

Orthopaedic / Rehabilitation technology – prostheses (exoprostheses) PDF262KB

 

·                     2015.10.13 Safety Notice for the Patient Data Manager, Brainlab AG

Radiological technology – auxiliary equipment and supplies for radiology / nuclear medicine PDF952KB

 

·                     2015.10.13 Safety Notice/Corrective action for Leica ASP200S / Leica ASP300S, Leica Biosystems Nussloch GmbH

In-vitro diagnostics – haematological, histological and cytological products PDF43KB

 

·                     2015.10.13 Corrective action for Bulk Loader Module (BLM), Roche Diagnostics

In-vitro diagnostics – equipment / products for clinical chemistry PDF73KB

 

·                     2015.10.13 Urgent Safety Notice – Silimed Implants, SILIMED – lndustria de lmplantes Ltda

Non-active implants – special implants PDF2MB

 

·                     2015.10.13 Security Advice for IC Kit lot with the number 091501, GFE Blut mbH

In-vitro diagnostics – microbiological products PDF110KB

 

·                     2015.10.13 Recall for the product Cutilyth sensitive Gel / Neutrosteralyth-Gel, AQUIS GmbH

Dressings / Pads – ointments and gels PDF62KB

 

·                     2015.10.13 Field Safety Notice using EN3-10 transducer and E-CUBE 9,ALPINION MEDICAL SYSTEMS Co., Ltd.

Ultrasonics – ultrasonic diagnostic equipment PDF93KB

 

·                     2015.10.13 FIELD SAFETY NOTICE – Brainlab Radiation Treatment Planning Software, Brainlab AG

Radiotherapy / Radiation protection – radiotherapy treatment planning systems PDF702KB

 

·                     2015.10.13 Field Safety Notice for EndoWrist instruments used with the da Vinci® Xi™ Surgical System, Intuitive Surgical, Inc.

Surgical equipment/ Anaesthesia – surgical equipment PDF528KB

 

·                     2015.10.13 Corrective action for the Alaris™ CC, GH, GS, PK and TIVA Syringe pumps, CareFusion

Injections / Infusions / Transfusions / Dialysis – infusion technology PDF88KB

 

·                     2015.10.13 MEDICAL DEVICE FIELD SAFETY NOTIFICATION Anspach G1 Dissection Tools, Synthes GmbH

Medical instruments for use in humans – bone surgery PDF5MB

 

·                     2015.10.13 Corrective action for the Anti-Leb, clone LEB2, CE-lmmundiagnostika GmbH

In-vitro diagnostics – haematological, histological and cytological products PDF971KB

 

·                     2015.10.13 MEDICAL DEVICE RECALL for IRMA TRUpoint® CC Cartridges, IRMA TRUpoint® BG Cartridges, KELLER MEDICAL GMBH

In-vitro diagnostics – equipment / products for clinical chemistry PDF2MB

 

·                     2015.10.13 URGENT: FIELD SAFETY NOTICE LifeCycle for Prenatal
Screening software Version v4.0 Rev4k, PerkinElmer

In-vitro diagnostics – equipment / products for clinical chemistry PDF2MB

 

·                     2015.10.13 Information for Filter LCR5 T/B, Macopharma

Injections / Infusions / Transfusions / Dialysis – equipment for collecting blood products and peripheral stem cells PDF93KB

 

·                     2015.10.12 Urgent Safety Notice for the Pinnacle Treatment Planning System, Philips Healthcare

Radiotherapy / Radiation protection – radiation facilites with accelerators for teletherapy PDF752KB

 

·                     2015.10.12 Expanded Corrective action for Spacelabs Healthcare Patient Monitor, Spacelabs Healthcare Inc.

Medical electronics / Electromedical devices – electrodiagnostics PDF86KB

 

·                     2015.10.12 Recall for the Neoss® Guide – Drill-Hub I and Neoss Guide Kit, Neoss Ltd.

Medical instruments for use in humans – bone surgery PDF52KB

 

·                     2015.10.12 Recall for specific lots of the Specialist 2 Intramedullary (SP 2 IM) Rod 400 mm Instrument, DePuy Orthopaedics, Inc.

Medical instruments for use in humans – bone surgery PDF234KB

 

·                     2015.10.12 Safety Notice for the Adipose Tissue Treatment Kits 2054-KTA2, Alcis

Non-active implants – materials for implants PDF2MB

 

·                     2015.10.12 Corrective action for specific da Vinci Si Single-Site gripping instruments, Intuitive Surgical

Surgical equipment/ Anaesthesia – surgical equipment PDF1MB

 

·                     2015.10.09 Urgent Field Safety Notice for cobas b 123 Sensor Cartridge BG/ISE/GLU/LAC, Roche

In-vitro diagnostics – equipment / products for clinical chemistry PDF269KB

 

·                     2015.10.09 Urgent Field Safety Notice for using GE Healthcare 3.0T MR Scanners

Electromedical fields – equipment for MR tomography PDF362KB

 

·                     2015.10.09  URGENT FIELD SAFETY NOTICE for MICroSTREP plus 1 (B1027-201), MICroSTREP plus 2 (B1027-202), and MICroSTREP plus 3 (B1016-89A), Beckman Coulter In-vitro diagnostics – microbiological products PDF1MB

 

·                     2015.10.09 URGENT FIELD SAFETY NOTICE, Recall of guide wires labeled with a 10-year expiration date, Zimmer Biomet

Medical instruments for use in humans – bone surgery PDF875KB

 

·                     2015.10.09 Urgent Medical Device Correction Notification for the NicoletOne Software v5.94, Natus Neurology lncorporated

Medical electronics / Electromedical devices – electrodiagnostics to the article

 

·                     2015.10.09 URGENT FIELD SAFETY NOTICE for ProcedurePak®, Mölnlycke Health Care

Surgical equipment/ Anaesthesia – surgical equipment PDF22KB

 

·                     2015.10.09 Urgent Field Safety Notice for ADVIA Chemistry XPT System, Siemens Healthcare Diagnostics Inc.

In-vitro diagnostics – equipment / products for clinical chemistry PDF35KB

 

·                     2015.10.09 Recall of specific lots of the EnVision™ FLEX/HRP visualization reagent, Dako

In-vitro diagnostics – equipment / products for clinical chemistry PDF78KB

 

·                     2015.10.09 URGENT FIELD SAFETY NOTICE for Zimmer Natural Nail CM Long, Zimmer Biomet

Non-active implants – bone surgery PDF106KB

 

·                     2015.10.08 Voluntary Recall of Specific Serial Numbers of ConforMIS Knee Replacement Systems, ConforMIS

Medical instruments for use in humans – bone surgery PDF144KB

 

·                     2015.10.08 Urgent Field Safety Notice for syngo® Lab Data Manager, Siemens Healthcare Diagnostics Inc.

In-vitro diagnostics – instruments, apparatuses and systems PDF39KB

 

·                     2015.10.08 Urgent Field Safety Notice for Liko® Viking® L, Viking® M, Viking® XL, and Viking® 300 Mobile Lifts, Hill-Rom

General equipment for medical treatment – ward equipment and equipment for emergency medical services PDF726KB

 

·                     2015.10.08 IMPORTANT FIELD SAFETY NOTICE, Dose and MU Incorrect, Product Monaco, Elekta

Radiotherapy / Radiation protection – radiotherapy treatment planning systems PDF113KB

 

·                     2015.10.08 URGENT FIELD SAFETY NOTICE for BD Vacutainer® Eclipse TM Signal™ Blood Collection Needle with lntegrated Holder, Becton, Dickinson U.K.Limited

Injections / Infusions / Transfusions / Dialysis – syringes and cannulas PDF2MB

 

·                     2015.10.08 URGENT FIELD SAFETY NOTICE for BD Affirm VPIII Microbial Identification Tests, Becton Dickinson France S.A.S. Belgian Branch

In-vitro diagnostics – microbiological products PDF71KB

 

·                     2015.10.08 lmportant customer safety notice for AXIOM Artis FA, FC, dFA, dFC, dFCM, AXIOM Artis BA, BC, dBA, dBC, dBCM and AXIOM Artis MP, dMP Systems with SW version VB23N/P, Siemens Healthcare GmbH

Radiological technology – radiological equipment for vascular diagnostics PDF4MB

 

·                     2015.10.08 Urgent Field Safety Notice for mylife OmniPod Insulin Management System

Injections / Infusions / Transfusions / Dialysis – infusion technology PDF73KB

 

·                     2015.10.08 Medical Device Recall for Sciatic Nerve Retractors

Medical instruments for use in humans – bone surgery PDF2MB

 

·                     2015.10.07 Installing a second EO Sensor for Low Temperature Sterilizer, DMB Apparatebau GmbH

General equipment for medical treatment – cleaning / disinfection / sterilisation PDF519KB