Materiovigilance – Liste Rückrufe

Medizinprodukte – Rückrufe und andere Sicherheitsmassnahmen (FSCA)
Datum Hersteller Handelsname Produktbeschreibung Informationen Referenz Nr. Swissmedic
22.08.2016 Bard Medical Division

Bard Hydrogel Coated Prostatic Catheter
Model 1857H20
Lot: MYZAR092

MD: Indwelling urethral drainage catheter

de

en

Vk_20160809_04
22.08.2016 Nutricia Medical Devices BV

Flocare Infinity Enteral feeding pump
Model 35676, 35677, 35679, 35680, 35682, 35683, 35685

MD: Enteral feeding pump

de

Vk_20160810_09
22.08.2016 bioMérieux SA

Mueller Hinton 2 + 5% sheep blood agar (MHS)
Model 43321, 43329, 43324
Lot: All

IVD: General-microorganism antimicrobial susceptibility culture medium IVD

de

fr

en

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22.08.2016 E&L medical systems

Clinic WinData
Software Version: 8.04.52

MD: X-ray film, diagnostic imaging

en

Vk_20160810_06
22.08.2016 ResMed Ltd.

Astral 100

 

Astral 150
S/N: See FSN

MD: Portable ventilator, electric

de - 1

de - 2

fr - 1

fr - 2

it - 1

it - 2

Vk_20160815_09
22.08.2016 Becton, Dickinson and Company

BD Vacutainer® Push Button Blood Collection Set
Model 367342
Lot: 5355533; 5356681

MD: Blood collection/intravenous fluid administration set

de

en

Vk_20160815_05
22.08.2016 Siemens Healthcare Diagnostics Inc.

ADVIA Centaur Systems PSA
Model SMN 10310292 , SMN 10310293
Lot: all

IVD: Total prostate specific antigen (PSA) IVD, kit, chemiluminescent immunoassay

de

fr

en

Vk_20160811_04
22.08.2016 LeMaitre Vascular, Inc.

Hydro LeMaitre Valvulotome
Model 1009-00, 1009-00J
Lot: see fsn

MD: Valvulotome

de

fr

it

en

Vk_20160809_08
22.08.2016 Thermo Fisher Scientific Microbiology Basingstoke

Update

ThermoScientific Oxoid Columbia Blood Agar Base
Model CM0331 (B,R,S,T,U)
Lot: see letter

IVD: Culture media, non-selective and non-differential

en - 1

en -2

Vk_20160712_14
16.08.2016 Hamilton Medical AG

HAMILTON-MR1
Model 161010
S/N: All serial numbers between 2001 and 2103

MD: Ventilators, transport

de

fr

it

en

Vk_20160805_04
16.08.2016 Sorin Group Italia Srl

PLATINIUM
Model VR 1210, VR 1240, DR 1510, DR 1540, CRT-D 1711, CRT-D 1741, SONR CRT-D 1811, SONR CRT-D 1841

AIMD: Single-chamber implantable defibrillator

en

Vk_20160805_05
16.08.2016 Beckman Coulter, Inc.

UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System
Model 775222
S/N: all

IVD: Specimen processing instrument IVD, automated

de

fr

en

Vk_20160809_01
16.08.2016 Medtronic Physio-Control

LIFEPAK CR Plus
Model 3202359-XXX

 

Lifepak Express
Model 3202177-XXX

MD: Rechargeable public automated external defibrillator; Semi-automated external defibrillator

de

fr

it

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16.08.2016 Siemens Healthcare GmbH

AXIOM Artis; Artis zee; Artis Q/Q zen
Model all
S/N: all

MD: Stationary angiographic x-ray system, digital

de

fr

it

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16.08.2016 Biomerieux

BK Virus R-gene® Real-time Detection and Quantific
Model 69-013B
Lot: 1003909940; 1004754140; 1004764070; 1004927000

IVD: BK virus (BKV) nucleic acid IVD, kit, nucleic acid technique (NAT)

de

fr

en

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16.08.2016 RBC Bioscience Corp

MagCore® Vi ral Nucleic Acid Extraction Kits
Lot: All the lots

IVD: Nucleic acid sample preparation instrument IVD, automated

en

Vk_20160729_01
16.08.2016 Terumo CORPORATION

MISAGO Self-Expanding Stent System
Model Product codes start with SX-V
Lot: all

MD: Multiple peripheral artery stent, bare-metal

de

fr

it

en

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16.08.2016 Spiggle & Theis Medizintechnik GmbH

Inflation Device
Model 2080-9030020
Lot: 15082596

MD: Catheter-balloon inflator, single-use

de

en

Vk_20160804_05
16.08.2016 Medtronic CoreValve LLC

ENVEO R DELIVERY SYSTEM
Model ENVEOR-L
Lot: all

MD: Aortic transcatheter heart valve bioprosthesis, stent-like framework

en

Vk_20160804_03
16.08.2016 Alcon Laboratories Inc.

AcrySof IQ IOL with ULTRASERT Delivery System
Model AU00T0.175, AU00T0.195, AU00T0.220
Lot: 12407022, 12407085, 12407087, 12409013, 12409024, 12409026, 12409028

MD: Posterior-chamber intraocular lens, pseudophakic

de

it

Vk_20160804_02
16.08.2016 Human Care HC Sweden AB

Altair
Model 55200-EU, 55200-GB, 55210-EU, 55210-GB, 55220-EU, 55220-GB
Lot: see FSN

 

Roomer S
Model 55300-EU, 55300-GB
Lot: see FSN

 

HeliQ
Model 55100-EU, 55100-GB, 55110-EU, 55110-GB, 55120-EU, 55120-GB, 55130-EU, 55130-GB, 55140-EU, 55140-GB, 55150-EU, 55150-GB
Lot: see FSN

MD: Stationary patient lifting system, line-powered

fr

en

Vk_20160725_11
16.08.2016 Mölnlycke Health Care AB

Umbilical clamp included in ProcedurePak kits and trays
Model umbilical clamp ref: IFKR21 & 2305123-00

MD: Obstetrical/gynaecological surgical kit, non-medicated, single-use

de

fr

it

en

Vk_20160805_01
16.08.2016 MEDOS Medizintechnik AG

Deltastream HC
Model ME DPHC 0001; ME DPHC 0002
S/N: DP-HC0003 bis DP-HC0296DP-HC1002 bis DP-HC1010DP-NT0001 bis DP-NT0111; TCU0001 bis TCU0007

 

NovaTherm
Model 4000127; 4000122
S/N: DP-HC0003 bis DP-HC0296DP-HC1002 bis DP-HC1010DP-NT0001 bis DP-NT0111; TCU0001 bis TCU0007

 

i-cor console
Model 5000101; 5000100

Cardiopulmonary bypass system heating/cooling unit

de

Vk_20160722_23
16.08.2016 Ergo-Fit GmbH & Co. KG

XRCISE STRESS ECHO
Model V5801-0101, V5801-0102, V5801-0103, V5801-0104
S/N: see FSN

MD: Stress test table

de

en

Vk_20160712_17
16.08.2016 Siemens Healthcare Diagnostics Inc.

Update

Dimension Vista System Flex reagent cartridge BUN
Model K1021
Lot: see FSN

IVD: Blood Urea Nitrogen (BUN) IVD, kit, enzyme spectrophotometry

de

de - Update

fr

fr - Update

en

en - Update

Vk_20160304_01
08.08.2016 Randox Laboratories Ltd

Lipase
Model LI3837 LI7979 LI8050 LI8361

IVD: Lipase Reagent

fr

it

en

Vk_20160726_06
08.08.2016 Siemens Healthcare Diagnostics Inc.

Xprecia Stride Coagulation Analyzer
Model 10714595
Software Version: DMS CD V1.0

IVD: Home-use/point-of-care coagulation analyser IVD, battery-powered

de

fr

en

Vk_20160728_08
08.08.2016 Intuitive Surgical, Inc

IS4000 EndoWrist Stapler 45
Model 470298
Lot: see fsn

 

IS4000 EndoWrist Stapler 30
Model 470430
Lot: see fsn

 

IS4000 EndoWrist Stapler 30 Curved-Tip
Model 470530
Lot: see fsn

MD: Endoscopic motorized cutting stapler

de

fr

en

Vk_20160728_09
08.08.2016 Philips Healthcare

IntelliVue Patient Monitor
Model MX400 866060; MX430 866061; MX450 866062; MX500 866064; MX550 866066
Lot: see FSN

MD: Transportable physiologic monitoring system

de

fr

en

Vk_20160728_05
08.08.2016 Philips Medical Systems Nederland BV

Multidiagnost Eleva, MultiDiagnost Eleva with Flat Detector and UroDiagnost Eleva systems.
Model 708032, 708033, 708034, 708036, 708037, 708038
S/N: several

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

de

fr

it

en

Vk_20160727_09
08.08.2016 N.G.C. Medical srl

Kit for pericardiocentesis and Pericardiocentesis Set
Model LMP003P6-K1 and LMP003P6
Lot: 16-0301316; 16-0301326; 16-0402005; 16-0402006; 16-0502111; 16-0502468; 16-0502468; 16-0502497; 16-0502523; 16-0602587; 16-0602947

MD: Pericardiocentesis catheter

it

en

Vk_20160727_02
08.08.2016 Direct Flow Medical

DFM Transcatheter Aortic Valve System
Model PL 9089
S/N: All

MD: Aortic transcatheter heart valve bioprosthesis, fluid-filled framework

de

fr

it

en

Vk_20160726_04
08.08.2016 Greatbatch Medical

Standard Offset Cup Impactor
Model see FSN

MD: Orthopaedic implant driver

de

fr

it

en

Vk_20160802_05
08.08.2016 The Binding Site Group Ltd

Optilite Analyser
Model IE700

IVD: Laboratory single channel clinical chemistry analyser IVD, automated

de

en

Vk_20160802_03
08.08.2016 Fresenius Kabi AG

HERMANN GASTROSTOMY DRESSING SET
Model 7901081
Lot: 32101266

MD: Procedure Kit/Trays, Dressing

de

Vk_20160726_11
08.08.2016 Boston Scientific Corporation

Lotus Valve System
Model Model: H749LTV230, H749LTV250, H749LTV270; Catalogue: TV23, LTV25, LTV27
Lot: see FSN

MD: Transcatheter heart valve bioprosthesis, stent-like framework

de

fr

it

en

Vk_20160802_07
08.08.2016 Stanmore Implants Worldwide Limited

METS Femoral Plateau Plate
Model mkfp/Std5; mkfp/Std10; mkfp/Std15; mkfp/Std20; mkfp/Sm5; mkfp/Sm10; mkfp/Sm15; mkfp/Sm20
Lot: see FSN

MD: Knee arthroplasty wedge

de

fr

it

en

Vk_20160610_02
02.08.2016 Alere Technologies AS

Alere Afinion CRP
Model 1116060, 1116058 and1116059
Lot: 10182971, 10183049

IVD: C-reactive protein (CRP) IVD, reagent

de

fr

it

Vk_20160722_28
02.08.2016 Mathys AG Bettlach

twinSys double offset adaptor
Model 51.34.0189; 51.34.0190
Lot: 2167229; 2171467; 2173242; 2174186; 2167230; 2171466; 2174187

MD: surgical instrument

de

fr

it

en

Vk_20160720_05
02.08.2016 Maquet GmbH & Co. KG

Befestigungsstück
Model 1002.65A0
Lot: Fertigungszeitraum 2009 bis 2013

MD: Headrest

de - 1

de - 2

fr

it

en

Vk_20160720_03
02.08.2016 Medtronic Navigation Inc.

O-ARM 1000 Imaging System
Model BI-700-00027 and BI-700-00028
S/N: All

 

O-arm O2 Surgical Imaging System
Model BI-700-02000
S/N: all

MD: Portable general-purpose fluoroscopic x-ray system, digital; Radiographic/fluoroscopic unit, general-purpose

de - 1

fr - 1

fr - 2

it - 1

en - 1

en - 2

Vk_20160720_02
02.08.2016 Smith & Nephew, Inc.

WHIPKNOT Soft Tissue Cinch #5 Sutures
Model 7211015
Lot: See Attached

MD: Ligation clip, synthetic polymer, non-bioabsorbable

de

fr

it

en

Vk_20160720_01
02.08.2016 Biomet Inc.

various kits containing ACD-A vials
Model see fsn
Lot: see fsn

MD: plastic tube containing blood anticoagulant acid citrate dextrose A (ACD-A)

de

fr

it

en

Vk_20160722_13
02.08.2016 Novus Scientific AB

TIGR Matrix Surgical Mesh
Model NSTM1015E, NSTM1520E, NSTM2030E

MD: Multi-purpose surgical mesh, synthetic polymer, bioabsorbable

de

fr

it

en

Vk_20160722_01
02.08.2016 bioMérieux SA

Etest Colistin CO 0.016-256
Model 537300-537308
Lot: see FSN

IVD: Colistin minimum inhibitory concentration (MIC) IVD

de

fr

en

Vk_20160725_15
02.08.2016 Siemens Healthcare GmbH

Artis system with 19 inch live display
Model display references DSHC1914-DC with part number 10656055

MD: Stationary angiographic x-ray system, digital

de

fr

Vk_20160725_09
02.08.2016 Fisher & Paykel Healthcare GmbH & Co. KG

AIRVO2 Humidifier / myAIRVO2 Humidifier
Model PT101XX , PT100XX
S/N: 120521YYYYYY bis 160605YYYYYY

MD: High-flow heated respiratory humidifier

de

Vk_20160725_08
02.08.2016 Spacelabs Healthcare

UVSL Command Module
Model 91496
S/N: 1496-140337
Lot: Manifold Lot Codes: 128280, 129420, 129940, or 155640

MD: Power supply, no-break

de

it

en

Vk_20160725_04
02.08.2016 Smith & Nephew Inc.

Sterile RENASYS Transparent Film
Lot: see FSN

MD: Wound dressing kit, sterile

de

fr

it

en

Vk_20160725_07
02.08.2016 Rex Bionics Ltd

REX Rehab
S/N: REX-2013-0063

MD: Ambulation exoskeleton, clinical

fr

en

Vk_20160713_01
02.08.2016 Haemonetics Corporation

Update

Cell Saver Elite Processing Kit (225 mL)
Model CSE-P-225
Lot: 1115013; 1115100

MD: Blood-processing autotransfusion system set

de - 2

fr - 1

fr -2

en - 1

en - 2

Vk_20160418_03
25.07.2016 Thermo Fisher Scientific Microbiology Basingstoke

ThermoScientific Oxoid GC Agar Broth
Model CM0367 (B,R,T,Q)
Lot: see letter

IVD: Culture media, non-selective and differential

en

Vk_20160712_15
25.07.2016 TRUMPF Medizin Systeme GmbH + Co. KG

TruSystem 7500 SF/SB
Model 1717020; 1730732
S/N: see FSN

 

TrueSystem 7500 SM
Model 1717023
S/N: see FSN

 

TrueSystem 5500 SM
Model 1607822;
S/N: see FSN

 

SB ARTIS
Model 1501878
S/N: see FSN

 

TrueSystem 7000
Model 1604788, 1604786
S/N: see FSN

MD: Line-powered electromechanical operating table system; Battery-powered electromechanical operating table system; Universal operating table, electromechanical, battery-powered

de

fr

it

en

Vk_20160713_07
25.07.2016 Medivance

Arctic Sun Temperature Management System
Model 318-02, 318-02-02
Lot: NGZKY606, NGAP2009

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

de

en

Vk_20160713_06
25.07.2016 Intuitive Surgical, Inc.

IS4000 EndoWrist Stapler 45
Model 470298

 

IS4000 EndoWrist Stapler 30
Model 470430

 

IS4000 EndoWrist Stapler 30 Curved-Tip
Model 470530

MD: Endoscopic motorized cutting stapler

de

fr

en

Vk_20160714_04
25.07.2016 Peters Surgical

LAME ONDULEE DE DELBET (Delbet corrugated drain)
Model DESI 1; NART 2
Lot: NLOT 1, NLOT 2

MD: Closed-wound drain

fr

en

Vk_20160714_03
25.07.2016 bioMérieux SA

NucliSENS easyMAG Magnetic Silica
Model 280133
Lot: see letter

IVD: Nucleic acid extraction/isolation kit IVD

de

fr

en

Vk_20160712_05
25.07.2016 Synthes GmbH

Locking Screw Stardrive 2.4 mm, self-tapping, length 12 mm, TAN sterile
Model 412.812S
Lot: 9775771, 9724771

 

Locking Screw Stardrive 2.4 mm, self-tapping, length 12 mm, TAN
Model 412.812
Lot: 9744302, 9946065, 9699702, 9746853

MD: Orthopaedic bone screw, non-bioabsorbable, sterile; Orthopaedic bone screw, non-bioabsorbable, non-sterile

de

fr

it

en

Vk_20160718_04
25.07.2016 Natus Medical Incorporated

neoBLUE LED Phototherapy System
Model 010066, 010068, 010069, 010070
S/N: all devices and customers for the neoBLUE LED Phototherapy System from January 1, 2004 to present.

MD: Overhead infant phototherapy unit

de

fr

en

Vk_20160712_03
25.07.2016 Zimmer Orthopaedic Surgical Products

Zimmer Air Dermatome II
S/N: 00-8851-001-00, 00-8851-001-00, 00-8851-001-01, 00-8851-201-00, 00-8851-202-00, 00-8851-203-00, 00-8851-204-00, 00-8851-215-00, 00-8851-215-00
Lot: All

MD: Dermatome, pneumatic

de

fr

it

en

Vk_20160713_10
25.07.2016 DiaSys Deutschland Vertriebs-GmbH

Ganestin
Model 40102, 40103

IVD: Prothrombin time ( Quick Test )

de

fr

en

Vk_20160718_01
25.07.2016 Howmedica Osteonics Corp

Triathlon
Model Triathlon Modular Handle: 6541-4-808
Lot: see FSN

MD: Orthopaedic prosthesis implantation instrument, reusable

de

en

Vk_20160712_09
25.07.2016 Covidien llc

Valleylab Laparoscopic Electrodes
Model Refer to attachment A of the FSN
Lot: Refer to attachment A of the FSN

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

de

fr

it

en

Vk_20160715_01
25.07.2016 Philips Medical Systems Nederland BV

Allura Xper
Model 722026, 722027, 722028, 722029, 722033, 722034, 722035, 722038, 722039, 722058, 722059
Software Version: R8.2

 

UNIQ
Model 722026, 722027, 722028, 722029, 722033, 722034, 722035, 722038, 722039, 722058, 722059
Software Version: R 1.0

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

de

fr

it

en

Vk_20160713_05
25.07.2016 Philips Healthcare (Suzhou) Co.Ltd

DuraDiagnost
Model 712211, 712214
Software Version: 3.0.X (Rel. before 3.0.7); 4.0.X (Rel. bef. 4.0.6)

MD: Stationary basic diagnostic x-ray system, digital

de

en

Vk_20160713_04
25.07.2016 Roche Diabetes Care Spain SL

Update

Emminens eConecta
Software Version: v5.4HF12

IVD: Diagnostics & Clinical Interpretation Supporting Software

en - 1

en - 2

Vk_20160617_08
25.07.2016 Abbott Vascular Inc.

Update

ABSORB Bioresorbable Vascular Scaffold System
Model 1012462-08, 1012462-12, 1012462-18, 1012462-23, 1012462-28, 1012463-08, 1012463-12, 1012463-18, 1012463-23, 1012463-28, 1012464-12, 1012464-18, 1012464-23, 1012464-28
Lot: All

 

ABSORB GT1 Bioresorbable Vascular Scaffold System
Model 1234250-08, 1234250-12, 1234250-18, 1234250-23, 1234250-28, 1234300-08-1234300-12, 1234300-18, 1234300-23,1234300-28, 1234350-12, 1234350-18, 1234350-23, 1234350-28
Lot: All

MD: Bioabsorbable coronary artery stent, drug-eluting

de - 1

de - 2

fr - 1

fr - 2

it - 1

it - 2

en - 1

en - 2

Vk_20151202_11