Аналіз інформації за період 01.11.2015 – 30.11.2015, отриманої з іноземних систем повідомлення про продукцію, що становить серйозний ризик

Опубліковано 10.12.2015 о 00:00


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Urgent Safety Notice for BD Plastipack™ Syringes und BD™ Oral-Syringes included in the KitPacks®, Lohmann & Rauscher GmbH & Co. KG

Urgent Safety Notice for the Procedure Pak containing BD Plastipak syringes, Mölnlycke Health Care AB

Corrective action for PiGalileo Hip Pressfit Impactor NAV Instruments, Smith & Nephew

Corrective action for the Sofia® Legionella FIA, Quidel Corporation

Urgent Safety Notice for Masimo rainbow® Reusable Sensors (for rainbow SET® Devices with SpCO®, SpO2, and SpMet®), Masimo Corp.

Follow-up Information concerning the Camino® ICP-Monitor and Licox® PtO2-Monitor, Integra LifeSciences

Corrective action for the IntellaTip MiFi XP Asymmetric (N4) Curves, Boston Scientific Corp.

Recall for the Tracoe larynx stoma button, TRACOE medical GmbH

Recall of a single lot of the Maxican Titanium Screw 4.5x 55mm cannulated, Normed Medizin-Technik GmbH

Urgent Safety Notice for the product CD22 (S-HCL-1) APC (CE-IVD), Becton, Dickinson and Company (BD)

Safety Notice for the product Oncentra® Simulation v2.X, Elekta

 

Corrective action for the product Triathlon MIS Modular Distal Capture, Stryker Orthopaedics

Recall of one lot of Synex Vertebral Body Replacements, DePuy Synthes

 

Urgent Safety Notice for the InSync® III Cardiac Resynchronization Therapy Pacemakers (CRT-P), Medtronic

Recall for the Vented Paclitaxel Set, Baxter

Recall for Exeter Small Tapered Pin Reamer and Exeter Large Tapered Pin Reamer, Stryker® Orthopaedics

Corrective action for the XPer Flex Cardio Patient Monitoring System, Philips Healthcare

Urgent Safety Notice for the Refill set DUO (Auffüllset DUO), ECOMEDIS

Synthes GmbH: Recall for the Locking Screw Stardrive, self-tapping, 3.5 mm

Safety Notice for the MYLA® software, bioMérieux

Corrective action for the product Sydney IVF PVP, William A. Cook Australia Pty Ltd.

Corrective action for the Valve XS Atrium Lift Retractor Blades, Aesculap AG

Urgent Safety Notice for the BD Plastipack™ Syringes and BD™ Oral-Syringes (included in the Kit packs), Lohmann & Rauscher GmbH & Co KG

Corrective action for Armstrong Medical Humidification Chambers and Breathing Circuits containing Humidification Chambers, Armstrong Medical Ltd.

Corrective action for the Protektor Systems/XLTEK, Natus Medical Incorporated

Corrective action for the Revolution CT Scanners, GE Healthcare

Safety Notice for the ON-Q Pump with ONDEMAND Bolus Button, Halyard Health, Inc.

Extended Recall for the product ala®octa, alamedics GmbH & Co. KG

lmportant Safety Notice for Optional PS500 power supply unit in conjunction with Evita lnfinity V500, Babylog VN500 or Evita V300, Drägerwerk

Urgent Safety Notice for the MoPyc Stem PTR-S7, Tornier SAS

Urgent Safety Notice for the Philips Brilliance 16-Slice (Air), Brilliance 64 CT, Ingenuity Core, Ingenuity Core128, Brilliance CT Big Bore and Ingenuity Flex products, Philips Healthcare

Safety Notice for the Allura Xper FD systems with Release 8.2.16, Philips Healthcare

Recall for the Raucodrape Surgical Incise Drape, CeMed GmbH

lmportant Safety Notice for ECG electrodes, type 440, P. J. Dahlhausen & Co. GmbH

Safety notice for X-Workplace with SW version VD10E, Siemens Healthcare

MEDICAL DEVICE RECALL for Expert Tibial Nail 9.0 mm, cannulated, length 270 mm, Synthes

URGENT FIELD SAFETY NOTICE – Palindrome™ Chronic Catheter, Palindrome™ Precision Chronic Catheter,
Palindrome™ Precision H Chronic Catheter Kits, Medtronic

Urgent Field Safety Notice for ADVIA® Chemistry XPT Systems, Siemens Healthcare Diagnostics

Urgent Field Safety Notice – Recall for Hpm Roll on cuff, Hammarplast Medical AB

Safety Advisory Notice for SOMATOM Definition AS, Siemens Healthcare

Urgent Field Safety Notice for Insulin Syringe Reservoirs Model 1850 and 3070, Applied Diabetes Research

Urgent Field Safety Notice for Olympus KeyMed OFP-2 Flushing Pump Accessory- MAJ-1606 Instrument Channel
Adaptor, Olympus

URGENT Field Safety Notice for RIO Base Array, Stryker

Urgent Field Safety Notice for NovaSil Silicon Single Lumen Embolectomy Catheter, LeMaitre Vascular

Safety Notice for Artis systems with large display, Siemens Healthcare

MEDICAL DEVICE FIELD SAFETY NOTIFICATION for chronOS Inject Bone Void Filler, Synthes GmbH

Advisory Note for Field Action – Mandatory Software Update IOLMaster, Carl Zeiss Meditec

Urgent Field Safety Notification for Siaretron 1000 IPER Ventilator, SIARE ENGINEERING INTERNATIONAL

Recall of the CXI Support Catheter, Cook Medical Europe

Recall of Accu-Chek Insight Rapid infusion sets, Roche

Further Safety Information for the PARI SOLE N / PARI SOLE N Tracheo nebulisers, PARI GmbH

Corrective action for the 1C66 Triton Smart Ankle, Otto Bock HealthCare GmbH

Recall of select lots of the Amphirion® Deep PTA Balloon Dilation Catheter, Medtronic

Safety Notice for Optisure™ Dual Coil Defibrillation Leads, St. Jude Medical

Recall for the Kirschner wire, Zimmer GmbH

Safety Notice for the MiniMed 640G insulin pumps, Medtronic

Corrective action for the product MR Surgical Suite Option, GE Healthcare

Recall for the product GAMMEX® PF, Ansell N.P Sdn. Bhd.

Safety Notice for Centricity PACS-IW versions 3.5.0 through 3.7.3.9 SP2, 3.7.3 SPA10 and 4.0.1, GE Healthcare IT

Urgent Safety Notice for the Centricity PACS-IW with Universal Viewer and Centricity Universal Viewer, GE Healthcare IT

URGENT FIELD SAFETY NOTICE for HeartMate II® System Controller, THORATEC CORPORATION

URGENT FIELD SAFETY NOTICE for Harmonic ACE+7 codes HARH23, HARH36, HARH45, Ethicon Endo-Surgery

URGENT FIELD SAFETY NOTICE – Access CEA Reagent Kit, Beckman Coulter

Safety Advice – use of THUNDERBEAT forceps, Olympus

URGENT IMPORTANT FIELD SAFETY NOTICE for Product Monaco, Elekta

URGENT FIELD SAFETY NOTICE for PERI-LOC Volar Distal Radius 3 Hole Plate, Smith & Nephew, Inc.

Medical Device Recall for Spine-USS II Rod lntroduction Pliers, Synthes GmbH

Urgent Field Safety Notice for Urinary Metanephrines by HPLC, Bio-Rad Laboratories GmbH

Corrective action for the Beacon Tip Angiographic Catheters, Cook Incorporated

URGENT FIELD SAFETY NOTICE for PowerStar Bipolar Cable, ETHICON

URGENT FIELD SAFETY NOTICE for ORTHO VISION™ Analyzer for ORTHO BioVue® Cassettes, Ortho Clinical Diagnostics

URGENT FIELD SAFETY NOTICE – REMOVAL for Twist Drill 25×95 mm Cannulated 1,2 mm Thread 30 mm, AO – Shaft, Zimmer GmbH

Urgent Field Safety Notice for Enzygnost Anti-VZV/IgG – lower absorbance values, Siemens Healthcare Diagnostics

Urgent Field Safety Notice for cobas p 612 pre-analytical system, Roche

Urgent Field Safety Notice for ADVIA® Chemistry Systems
Hemoglobin A1c_3, Siemens Healthcare Diagnostics

IMPORTANT SAFETY INFORMATION for Soluscope Serie 4 PA, Soluscope SAS

URGENT FIELD SAFETY NOTICE for VariSourceiX Control Software, Varian

URGENT DEVICE RECALL NOTICE for Provide Protection Caps and Provide Impression Copings, BIOMET 3i

URGENT FIELD SAFETY NOTICE for T-Piece Circuit, Mercury Medical

Field Safety Notice for A/V Set DEHP-free PVC for Dialog and /or Single-Needle Adapter, B. Braun Avitum AG

URGENT MEDICAL DEVICE CORRECTION for ARIA® for Radiation Oncology, ARIA® Oncology Information System for Radiation Oncology, Varian

URGENT PRODUCT RECALL for PenBlade Safety Scalpels, ZIEN Medical Technologies

 

 

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