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


https://www.swissmedic.ch/rueckrufe_medizinprodukte/index.html?lang=en

 

 

Date

Manufacturer

Trade name

Product description

Information

Ref. № Swiss

30.11.2015

Breas Medical AB

Breas
Model Vivo 60, 216000
Software Version: 3.05 or below

MD: Portable ventilator, electric

de

fr

it

en

Vk_20151117_08

30.11.2015

Siemens Healthcare Diagnostics Inc

Dimension Integrated Chemistry Systems
Model 10472176, 10639338, 10444833, 10444828, 10444829, 10444831

IVD: Specimen processing instrument IVD, automated

de

fr

en

Vk_20151117_07

30.11.2015

Siemens Healthcare Diagnostics Inc

Stratus CS: Acute Care BHCG TestPak, Acute Care BHCG CalPak, Acute Care CCRP TestPak, Acute Care CCRP CalPak, Acute Care CKMB TestPak, Acute Care CKMB DilPak, Acute Care cTNI TestPak, Acute Care DDMR TestPak, Acute Care MYO TestPak, Acute Care MYO DilPak,
Lot: see FSN

IVD: CLINICAL CHEMISTRY

fr

en

Vk_20151117_04

30.11.2015

Siemens AG, Healthcare Sector, Buisness Unit AX

syngo X WP
Model 10502522
Software Version: VD10E

MD: Diagnostic x-ray digital imaging system workstation

de

fr

Vk_20151117_03

30.11.2015

Medica Europe

Custom Procedure Trays with a Covidien Devon Disposable Light Handle Cover
Model 571711
Lot: All batches with the light handle cover, which was manufactured between March 2012 and March 2015

MD: Operating/examination/treatment light handle cover, single-use

en

Vk_20151123_09

30.11.2015

Johnson & Johnson Medical GmbH

Imogas
Model Imogas Forte
Lot: 066624A

Gas induced gastro-intestinal pain relieve (soft gelatine capsules)

de

fr

Vk_20151125_25

30.11.2015

Synthesia, a.s.

Cellistypt, Cellistypt D-K and Cellistypt F
Model see FSN
Lot: see FSN

MD: Hemostatic media

en

Vk_20151119_07

30.11.2015

Medivance Inc.

Arctic Sun Temperature Management System
Model 5000-01-01; 5000-01-02; 5000-00-00
S/N: see FSN

MD: Circulating-fluid whole-body heating/cooling system control unit

de

fr

en

Vk_20151118_02

30.11.2015

Christoph Miethke GmbH & Co. KG

ProGav
S/N: See list
Lot: See list

MD: Ventriculo-peritoneal/atrial shunt valve

de

en

Vk_20151118_01

30.11.2015

Siemens Healthcare Diagnostics Products GmbH

Dimension Vista B2MIC Flex reagent cartridge
Model K7024
Lot: 15175MA,15204MA,15246MA,15267MA

IVD: Beta2-microglobulin kit

fr

en

Vk_20151118_04

30.11.2015

MAQUET Cardiopulmonary AG

Quadrox-iD adult and small adult
Model HLS, HIT, PLS
Lot: see FSN

MD: Extracorporeal membrane oxygenator

en

Vk_20151120_04

30.11.2015

BrainLAB AG

Brain Metastases
Software Version: 1.0.0

 

Adaptive Hybrid Surgery Analysis
Software Version: 1.0.0

MD: Radiation therapy treatment planning system

de

fr

it

en

Vk_20151120_12

30.11.2015

Carl Zeiss Meditec AG

IOLMaster 500
Model 000000-1692-983, 000000-1865-713, 000000-1977-827, 000000-2081-183
Software Version: 7.5.2, 7.7.2 and 7.7.3

MD: Optical low coherence reflectometry (OLCR) biometer

de

fr

Vk_20151123_02

30.11.2015

Terumo Medical Corporation

Terumo Destination Renal Guiding Sheath
Model RSR01
Lot: RN19

MD: Catheter introducer

de

fr

it

en

Vk_20151120_13

30.11.2015

Fehling Instruments GmbH & Co. KG

Flexible holding device f. sternum / thorax retra
Model MNU-1V

MD: Retractors, Self-Retaining Operating

de

en

Vk_20151120_07

30.11.2015

DiaMex GmbH

Optitrol A Multimarker Control
Model IN0202, IN0203, IN0204, IN0203S
Lot: see FSN

IVD: Multiconstituent Controls – Inf.Imm.

fr

en

Vk_20151123_

30.11.2015

Smith & Nephew Orthopaedics Ltd

Birmingham Hip Modular Head
Model 38MM~58MM Monoblock; catalogue: see FSN
Lot: All batches/lots

MD: Hip prosthesis, internal, femoral head component

de

fr

en

Vk_20151117_01

23.11.2015

Bayer Consumer Care AG

Contour NEXT Control Solution
Model 7335, 3329, 7340, 7336, 7341, 7330, 7336, 7342, 7337, 7331, 7342, 3329, 7340, 7336, 7341, 7330, 7336, 7342, 7337, 7331, 7342
Lot: all lots

IVD: Glucose IVD, control

de

fr

it

en

Vk_20151105_07

23.11.2015

Synthes GmbH

Expert Tibial Nail
Model 04.004.334
Lot: 3018420, 3405573

MD: Tibia nail, sterile

de

en

Vk_20151110_11

23.11.2015

Qiagen GmbH

artus C. trachomatis Plus RG & LC PCR Kits
Model 4559263, 4559265, 4559063, 4559065, 4559267

IVD: Chlamydia trachomatis detection by NA Reagents
CT Multiparameters Combination NA Reagents 15.30.04.41

de

fr

it

en

Vk_20151113_03

23.11.2015

OptiMed Medizinische Instrumente GMBH

sinus-Carotid-Conical-RX Stents
Model see FSN

MD: Coronary artery stent

de

en

Vk_20151110_04

23.11.2015

Mölnlycke Health Care AB

BARRIER EasyWarm active self-warming blanket
Model 629900, 629910
Lot: all products delivered prior Nov. 9, 2015

MD: Activated-medium surgical warming blanket

de

fr

it

en

Vk_20151110_05

23.11.2015

Medtronic Inc.

InSync III Cardiac Resynchronization Therapy Pacemakers
Model 8042
S/N: All

AIMD: Cardiac resynchronization therapy implantable pacemaker

de

fr

it

en

Vk_20151110_03

23.11.2015

A. Menarini Diagnostics S.r.l.

GlucoMen LX Sensor

IVD: Glucose rapid test system reagent

de

fr

it

en

Vk_20151113_07

23.11.2015

Invivo Corporation

Flex Cardio Patient Monitoring System
Model 453564243591 XPer Flex Cardio 2010 453564241901 XPer Flex Cardio 2010-Exchange, Catalogue: 860335 & 860338
S/N: See Unit Affected List

MD: Multi-patient physiologic monitoring system

de

fr

en

Vk_20151112_09

23.11.2015

Philips Medical Systems BV

Allura Xper FD
Model 722026, 722027, 722028, 722029, 722038, 722058, 722033, 722034, 722035, 722036, 722039, 722059
Software Version: R8.2.1.1

MD: Stationary general-purpose fluoroscopic x-ray system, analogue

de

fr

it

en

Vk_20151112_05

23.11.2015

Siemens AG, Healthcare Sector, Buisness Unit AX

Artis system equipped with a large display
Model AX025/15/S
Lot: see FSN

MD: Stationary angiographic x-ray system, digital

de

Vk_20151111_02

23.11.2015

Olympus Winter & Ibe GmbH

Video Telescope ENDOEYE HD II
Model WA50040A, WA50042A

MD: Flexible video laparoscope

de

fr

it

en

Vk_20151116_09

23.11.2015

alamedics GmbH & Co. KG

Update

ala octa
Model PN 101001, PN 101002, PN 101003, PN 101004

MD: Retinal tamponade medium, intraoperative

de – 1

de – 2

fr – 1

fr – 2

en – 2

VK_20151102_03

23.11.2015

Integra LifeSciences (Ireland) Ltd.

Update

Camino ICP Monitor
Model CAM02

 

Licox PtO2 Monitor
Model LCX02, LCX02R

MD: Intracranial pressure monitor; Tissue oxygen/temperature monitoring control unit

de – 1

de – 2

fr – 1

it – 1

it – 2

en – 1

en – 2

Vk_20150428_04

16.11.2015

Synthes GmbH

Locking Screw Stardrive, self-tapping, 3.5 mm
Model 412.104S, 412.105S, 413.016
Lot: 9137946, 9211047, 9043572, 9109629, 9137919, 9199768, 9215837

MD: Orthopaedic bone screw, non-bioabsorbable, sterile

de

en

Vk_20151106_01

16.11.2015

PARI GmbH

Pari Sole N 025

 

PARI SOLE N Tracheo

MD: Nebulizing system, heated

de

fr

it

en

Vk_20151106_06

16.11.2015

Ortho Clinical Diagnostics Inc.

VITROS 5600
Model 6802864
Software Version: 3.2 and below

 

VITROS 3600
Model 6802866
Software Version: 3.2 and below

IVD: Clinical chemistry analyser; Immunoassay analyser

de

en

Vk_20151106_13

16.11.2015

GE Medical Systems LLC

Revolution CT
Model 5480177
Software Version: 15MW03.12

MD: Full-body CT system

en

Vk_20151106_10

16.11.2015

Leonhard Lang GmbH

ECG Electrode
Model 58051
Lot: see FSN

MD: Electrocardiograph electrode

de – 1

de – 2

en – 1

Vk_20151109_09

16.11.2015

Human Care HC Sweden AB

Roomer S

 

Altair
S/N: All products manufactured before 2015-10-08

MD: Stationary patient lifting system, line-powered

en

Vk_20151105_01

16.11.2015

Thermo Fisher Scientific Microbiology Basingstoke

Oxoid Antimicrobial Susceptibility Testing Discs FOX30 (Cefoxitin)
Model CT0119B
Lot: 1689092, 1689093

IVD: Antibiotic susceptibility testing kit, bacterial

en

Vk_20151105_08

16.11.2015

Quidel Corporation

Sofia Legionella FIA
Model 20244

IVD: Legionella – Rapid Test

de – 1

de – 2

fr – 1

fr – 2

en – 1

en – 2

en – 3

Vk_20151105_06

16.11.2015

bioMérieux SA

MYLA software when connected to a VITEK 2 system
Model 414518, 415358, 416192, 416546, 417191, 419071, 419072
S/N: All installed systems connected to a VITEK2 system
Software Version: 414518 V3.2 CLI, 415358 V3.2 CLI, 416192 V3.3 CLI, 416546 V4.0 CLI, 417191 V4.1 CLI, 419071 V4.1 CLI, 419072 V4.1 CLI

IVD: Microbial identification mass spectrometry system IVD

de

fr

en

Vk_20151105_04

16.11.2015

Thermo Fisher Scientific Microbiology Basingstoke

Oxoid Antimicrobial Susceptibility Testing Disc CN10 (Gentamicin)
Model CT0024B
Lot: 1686823

IVD: Antibiotic susceptibility testing kit, bacterial

en

Vk_20151104_05

16.11.2015

LeMaitre Vascular, Inc.

LeMaitre Over-the-Wire Embolectomy Catheters
Model 1651-38, 1651-48, 1651-64, 1651-78, 1651-88
Lot: OTW3080, OTW3084, OTW3124, OTW3079, OTW3069, OTW3088, OTW3097

 

NovaSil Silicon Single Lumen Embolectomy Catheter
Model 1801-68
Lot: NSE 1663

 

LeMaitre Single Lumen Embolectomy Catheter
Model 1601-38, 1601-48, 1601-58
Lot: SLC3663, SLC3636, SLC3668, SLC3637

MD: Thrombectomy balloon catheter

de – 1

de – 2

de – 3

fr – 1

fr – 2

fr – 3

it – 1

it – 2

it – 3

en – 1

en – 2

en – 3

Vk_20151103_09

16.11.2015

St. Jude Medical

Optisure Dual Coil Defibrillation lead
Model LDA 220 Q52, LDA 220 Q58, LDA 220 Q65 and LDP 220 Q58
S/N: Total of 1121 leads are affected. Of which 164 have been implanted or are in hospital inventory outside US.

AIMD: Endocardial defibrillation lead

de

fr

it

en

Vk_20151105_03

16.11.2015

Implant Direct Sybron Manufacturing LLC

DirectGuide Drill Extender
Model DGDE
Lot: 61928, 64895, 64898, 64896, 65406, 65405, 65407, 65408, 65410, 65409, 65357, 67055, 67475, 67345, 37475, 67476, 67474, 67478, 67477, 67479, 67527, 68254, 68266, 68253, 68265, 68262

MD: Dental drill extension

de

en

Vk_20151106_02

16.11.2015

ArthroCare Corporation

Cavity SPINEWAND Device, 8-gauge
Model KP-CAV-7705-01
Lot: 1024313, 1024482, 1027160, 1034306, 1041879, 1059328

MD: Universal foot-controlled electrosurgical diathermy system conducting unit, single-use

de

Vk_20151104_02

16.11.2015

Becton Dickinson and Company

CD22 (S-HCL-1) APC
Model 333145
Lot: 4335641, 4352613, 5061915, 5139958

IVD: B/T-cell subtyping antibody kit

de

it

en

Vk_20151106_08

09.11.2015

Quest Medical Inc.

Myocardial Protection System (MPS) Delivery Set
Model 5001102, 5001102-AS, and 7001102
Lot: see FSN

MD: Cardioplegia solution administration kit

en

Vk_20151102_02

09.11.2015

bioMérieux

Densitometer Densimat
S/N: IDN016182 to IDN016268 except IDN016242

 

ATB Densitometer Control Kit Re
Lot: 1003780430, 1003838260, 1003848040, 1003883560, 1003990940, 1004040130, 1004089920, 1004121270, 1004149420

IVD: Densitometer

de – 1

fr – 1

en – 1

en – 2

Vk_20151030_06

09.11.2015

Bridge to Life (Europe) Ltd.

Belzer UW Cold Storage Solution
Model BTLBUW-1000, BTLBUW-2000
Lot: CBD121914, CBE031915

MD: General-purpose donor-organ preservation/transport system

it

en

Vk_20151029_01

09.11.2015

AngioScore Inc.

AngioSculpt PTA Scoring Ballon Catheter
Model 2076-6040 and 2001-3515
Lot: F15060018 and F15060049

MD: Angioplasty catheter

de

fr

Vk_20151030_05

09.11.2015

Covidien llc

Palindrome Chronic Catheter
Model 8888145042
Lot: see FSN

 

Palindrome Precision Chronic Catheter
Model 8888145017P ; 8888145042P
Lot: see FSN

 

Palindrome Precision H Chronic Catheter
Model 8888145046C
Lot: see FSN

MD: Double-lumen haemodialysis catheter, implantable

de

it

en

Vk_20151027_01

09.11.2015

Philips Healthcare

HeartStart MRx Defibrillator/ Monitor
Model M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6

MD: Defibrillator/monitor

de

fr

it

en

Vk_20151027_09

09.11.2015

Mölnlycke Health Care AB

ProcedurePak
Model ProcedurePak containing BD Plastipak syringes
Lot: See list

MD: General surgical procedure kit, non-medicated, single-use

de

fr

it

en

Vk_20151027_07

09.11.2015

Soluscope SAS

SOLUSCOPE endoscope washer-disinfector
Model serie 4 PA
S/N: 00022342, 00021985, 00021993, 00022302, 00021995

MD: Flexible endoscope washer

de

fr

en

Vk_20151005_01

09.11.2015

Hammarplast Medical AB

Hpm Roll-on cuff

MD: Cuff

de

fr

it

en

Vk_20151027_03

02.11.2015

Philips Medical Systems BV

Allura Xper
Model 722026, 722027, 722028, 722029, 722033, 722034, 722035, 722036, 722038, 722039, 722058, 722059
Software Version: R8.2.16

MD: Stationary general-purpose fluoroscopic x-ray system, analogue

fr

en

Vk_20151020_02

02.11.2015

Otto Bock HealthCare GmbH

Genu Arexa
Model 50K13N

MD: Knee orthosis

de

en

Vk_20151020_01

02.11.2015

Synthes GmbH

Orthopaedic implant impacto
Model 03.037.025
Lot: 8911887, 8911975, 9166356, 9285766, 9286671, 9319408, 9375245, 9375251, 9388359, 9388360, 9393071, 9393074, 9393075, 9393076, 9409795, 9409796, 9422892, 9422895, 9498455, 9310899, 9310900, 9319407

MD: Orthopaedic implant impactor

de

fr

en

Vk_20151021_07

02.11.2015

B. Braun Melsungen AG

SPIRAL LINE
Model 4092945, 4092953, 4092970
Lot: see FSN

MD: Intravenous administration tubing extension set

de

fr

it

Vk_20151021_01

02.11.2015

Olympus Medical Systems Corp.

EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE
Model GF-UCT180
S/N: all

MD: Gastroscopes, Flexible

de

fr

en

Vk_20151023_11

02.11.2015

Invatec SpA

Amphirion Deep PTA Balloon Dilation Catheter
Model see FSN

MD: Peripheral angioplasty balloon catheter

de

fr

it

Vk_20151023_10

02.11.2015

Newdeal SAS

BOLD 2.5mm compression screw
Model 200010, 200010S, 200016, 200016S
Lot: F9SP and FAGJ

MD: Orthopaedic bone screw, non-bioabsorbable, sterile

it

en

Vk_20151023_04

02.11.2015

Allergan Limited

Natrelle 133 Plus
Model see FSN

MD: Tissue expander

de

en

Vk_20151023_02

02.11.2015

William A. Cook Australia Pty Ltd

SYDNEY IVF PVP
Model K-SIPV-200-5
Lot: Master batch M06150612

MD: IVF medium kit

de

fr

it

Vk_20151023_03

02.11.2015

Roche Diabetes Care GmbH

Accu-Chek Insight Rapid
Model 00700008451, 00700008452, 00700008453, 00700008454, 00700008455, 00700008456, 00700008457, 00700008458, 00700008459
Lot: All

MD: Electric infusion pump administration set

de – 1

de – 2

fr – 1

fr – 2

it -1

it – 2

en – 1

en – 2

Vk_20151026_07

02.11.2015

Olympus KeyMed KeyMed House, Stock Road

Olympus Instrument Channel Adaptor
Model MAJ-1606
Lot: LOT20115441 & LOT20116536

MD: Endoscope channel support kit

de – 1

de – 2

fr – 1

fr – 2

en – 1

Vk_20150903_02

02.11.2015

Becton Dickinson and Company Limited

BD Plastipak Syringe

 

BD Oral Syringe

MD: General-purpose syringe; Oral medicine administration kit

de – 1

de – 2

fr – 1

fr – 2

it – 1

en – 1

Vk_20150922_06

 

 

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