Materiovigilance – list of recalls

Medical devices – List of recalls and other field safety corrective actions (FSCA)
Date Manufacturer Trade name Product description Information Reference number Swissmedic
23.05.2017 Joh. Stiegelmeyer GmbH & Co. KG

Sicuro Plus
Model: 5369, Catalogue: 146562; 114787
S/N: all

MD: Bed, electric

de

Vk_20170425_11
23.05.2017 Covidien llc

POLYSORB suture
Model See FSN
Lot: See FSN

 

Endo Stitch
Model see FSN
Lot: see FSN

 

Maxon Monofilament Absorbable Suture
Model see FSN
Lot: see FSN

 

Biosyn Suture
Model see FSN
Lot: see FSN

MD: Polyglactin suture; Suture knot-tying device; Polyglyconate suture

de

fr

en

Vk_20170510_04
23.05.2017 ArcRoyal Ltd

Inflation Device 30 atm

MD: Catheter-balloon inflator, single-use

de

fr

it

en

Vk_20170510_02
23.05.2017 KCI USA, Inc

1000 ml Canister (with Gel) for InfoV.A.C. and V.A.C.ULTA Therapy Systems
Model M8275093/5
Lot: see letter

MD: Negative-pressure wound therapy system canister

de

en

Vk_20170509_07
23.05.2017 MEDTECH

ROSA Brain
Model ROSA Brain 3.0.0
S/N: BR16027

MD: Neurological stereotactic surgery system

fr

en

Vk_20170515_04
23.05.2017 Covidien llc

Endo Peanut Auto Suture Blunt Dissector 5mm
Model 173019 (for affected kits see fsn)
Lot: M5K04X to M7A01X (for affected kits see fsn)

MD: Laparoscopic blunt dissector

de

fr

it

en

Vk_20170516_03
23.05.2017 Elekta Instrument AB

Leksell Gamma Knife Icon
Model 1515698
S/N: 6018, 6047, 6090, 6094, 6171, 8018

MD: Teletherapy radionuclide system

de

fr

en

Vk_20170511_02
23.05.2017 Balt Extrusion

SONIC1.5F

MD: Intravascular microflow catheter

de

fr

en

Vk_20170511_08
23.05.2017 Roche Diagnostics GmbH

cobas 6800 System
Model 05524245001
Software Version: SW 01.00.12, SW 01.01.09, SW 01.01.10, SW 01.02.12

 

cobas 8800 System
Model 05412722001
Software Version: SW 01.00.12, SW 01.01.09, SW 01.01.10, SW 01.02.12

 

Cobas MPX

 

cobas DPX Test

IVD: Thermal cycler nucleic acid amplification analyser IVD, automated; HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT); Others Virus Combination - Multiplex NA Reagents

de

fr

en

Vk_20170516_02
23.05.2017 Vascular Solutions Inc.

Venture RX Catheter, Venture OTW Catheter, and Venture CS Catheter
Model 5820, 5821, 5822
Lot: see fsn

MD: Peripheral/coronary vascular infusion catheter

de

fr

en

Vk_20170505_01
23.05.2017 Mölnlycke Health Care AB

Update

Brennen Skin Graft Mesher
Model 131600, 131601, 131602, 131603, 131604, 131500, 131501, 131502, 131503, 131504, 131506

MD: Skin graft mesher

de

en

en - Update

Vk_20170428_09
23.05.2017 BioMérieux Inc.

Update

VITEK 2 GN ID, VITEK 2 GP ID, VITEK 2 YST ID, VITEK 2 BCL ID, VITEK 2 NH ID, VITEK 2 ANC ID, VITEK 2 AST
Model see letter
Lot: see letter

IVD: MICROBIOLOGY (CULTURE)

de

de - Update

fr

fr - Update

en

en - Update

Vk_20170421_17
16.05.2017 Implant Direct Sybron Manufacturing LLC

Legacy P Implant
Model 8037P10
Lot: 86554

MD: Dental implant system

fr

it

en

Vk_20170508_02
16.05.2017 Cardiovascular Systems Inc

OAS Pump
Model SIP-3000, catalogue: 7-10014-xx
Lot: 136881, 137221, 138614, 172379
Software Version: FW-0003 Rev A

MD: Atherectomy system saline/lubricant pump

de

Vk_20170502_13
16.05.2017 Abbott Ireland Diagnostics Division

ARCHITECT Free T4 Reagent Kit
Model 7K65-29; 7K65-34; 7K65-39
Lot: 65349UI00; 65349UI01; 68194UI00; 68194UI01; 68196UI00; 68196UI01; 71292UI00; 71292UI01; 71374UI00; 71374UI01; 65415UI00; 68241UI01; 70273UI01; 71339UI00; 73200UI01; 74137UI00; 65415UI01; 68241UI00; 70273UI00; 71339UI01; 73200UI00; 74137UI01

IVD: Free thyroxine (FT4) IVD, kit, chemiluminescent immunoassay

de

fr

it

en

Vk_20170502_08
16.05.2017 Mikrogen GmbH

recomWell Campylobacter lgG
Model 6204
Lot: ECJ111602

IVD: Other Campylobacter Reagents

de

en

Vk_20170503_12
16.05.2017 Siemens Healthcare GmbH; Business Area Advanced Therapies

Sensis System
Model all

MD: Cardiac catheterization laboratory computer

de

fr

it

Vk_20170503_05
16.05.2017 Leica Microsystems (Schweiz) AG

Leica M525 F40
S/N: All

MD: General-purpose surgical microscope

de

en

Vk_20170508_03
16.05.2017 Beckman Coulter, Inc.

Access Total T3
Model 33830
Lot: all lots

 

Access Thyroglobulin Assay
Model 33860
Lot: all lots

 

Access Free T4
Model 33880
Lot: all lots

 

Access GI Monitor
Model 387687
Lot: all lots

IVD: Reverse triiodothyronine (reverse T3) IVD, kit, chemiluminescent immunoassay; Thyroglobulin IVD, kit, chemiluminescent immunoassay; Free thyroxine (FT4) IVD, kit, chemiluminescent immunoassay; Cancer antigen 19-9 (CA19-9

de

fr

en

Vk_20170508_13
16.05.2017 LivaNova Deutschland GmbH

Heater-cooler (1T), Heater-cooler 3T, FlexTherm
Model 16-02-50, 16-02-80, 16-02-81, 16-02-82, 16-02-83, 16-02-85, 16-02-95, 16-70-00
S/N: All

MD: Cardiopulmonary bypass system heating/cooling unit

de

fr

it

en

Vk_20170508_09
16.05.2017 Beckman Coulter, Inc.

UniCel DxH 800 Coulter Cellular Analysis System
Software Version: all

 

UniCel DxH 600 Coulter Cellular Analysis System
Software Version: all

IVD: Haematological cell analyser IVD, automated

de

fr

en

Vk_20170426_04
16.05.2017 Mölnlycke Health Care AB

Barrier Sets
Model 60611-01; 60612-01

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

de

fr

en

Vk_20170504_07
16.05.2017 Medtronic Inc.

Update

Claria MRI, CRT-D SureScan and Amplia MRI CRT-D
Model DTMA2D1, DTMA2D4, DTMA2Q1, DTMA2QQ, DTMB1D4, DTMB1QQ, DTMB2D1, DTMB2D4, DTMB2Q1, DTMB2QQ
S/N: all

AIMD: Polymeric urethral stent, long-term

de

fr

it

en - 1

en - Update

Vk_20161212_06
08.05.2017 ATMOS MedizinTechnik GmbH & Co KG

HARTMANN Vivano tec
Model 409 504
S/N: 100037296, 100028065, 100009729
Software Version: 1.2

 

ATMOS S 042 NPWT
Model 316.0000.0
Software Version: 1.2

MD: Wound suction system, electric

de

fr

en

Vk_20170428_04
08.05.2017 Olympus Winter & Ibe GmbH

HF-resection electrode, loop, 24 Fr., 12 degree
Model A22201A
Lot: P16X0003, P1690004

MD: Electrodes, Electrosurgical

de

en

Vk_20170427_02
08.05.2017 Ossur hf

Halo Vest/Lil Angel Halo Vest
Model 545700L, 545100L, 545800L, 545100K, 545700K 545100S
Lot: All

MD: Cervicothoracic spine orthosis

de

fr

en

Vk_20170501_06
01.05.2017 Siemens Healthcare Diagnostics Inc.

ADVIA Centaur Insulin
Model SMN 10310439, SMN 10310438
Lot: see letter

IVD: Insulin IVD, kit, chemiluminescent immunoassay

de

fr

en

Vk_20170418_23
01.05.2017 AIR LIQUIDE MEDICAL SYSTEMS

MONNAL T50
Model KC027500, KC037600, KC039100
S/N: all

MD: Neonatal/adult intensive-care ventilator

de

fr

en

Vk_20170419_01
01.05.2017 Shenzhen Mindray Bio-medical Electronics Co.,Ltd

Beneview T1 Patient Monitor
S/N: See FSN

MD: Single-patient physiologic monitoring system

de

fr

it

Vk_20170420_02
01.05.2017 Abbott

ARCHITECT SHBG Reagent Kit
Model 8K26-20; 8K26-25
Lot: 01916E000; 00316F000; 01816G000; 00916I000; 07316I000; 00916L000; 01816E000; 00216F000; 01716G000; 00816I000; 07216I000

IVD: Sex hormone binding globulin (SHBG) IVD, kit, chemiluminescent immunoassay

de

fr

en

Vk_20170419_08
01.05.2017 Beckman Coulter, Inc.

Access BR Monitor
Model 387620
Lot: See FSN

IVD: Cancer antigen 15-3 (CA15-3) IVD, kit, enzyme immunoassay (EIA)

de

fr

it

en

Vk_20170410_08
01.05.2017 AMO Uppsala AB

Healon GV
Lot: UB32577, UB32597

 

Healon
Lot: UB32514, UB32519, UB32522, UB32538, UB32574, UB32579, UB32594, UB32600, UB32604

 

Healon 5 Pro
Lot: UB32526

 

Healon Pro
Lot: UB32524

MD: Vitreous/aqueous humour replacement medium, intraoperative

de

fr

en

Vk_20170420_10
01.05.2017 LAMIDEY NOURY MEDICALZA les Godets

MCB PLASMA EDGE
Model V10GMCB
S/N: V2 - PK8

MD: Electrosurgical system generator

fr

Vk_20170427_01
24.04.2017 Siemens Healthcare Diagnostics Inc.

RAPID Point 500 Blood Gas Analyzer
Model 10492730, 10696857, 10697306
S/N: All Serial numbers with V2.4 Software
Software Version: V2.4

IVD: Point-of-care blood gas/haemoximetry analyser IVD

en

Vk_20170413_16
24.04.2017 Siemens Medical Solutions USA, Inc. Ultrasound Group

ACUSON S Family
Model 10441701, 10041461, 10440017, 10441730
Software Version: VD10A, VD10C

MD: General ultrasound imaging system, line-powered

de

fr

it

Vk_20170418_20
24.04.2017 Arthrex INC

Self-Punching SwiveLocks
Model AR-2323BSLM, AR-2323PSLM, AR-2324BCM, AR-2324PSLM, AR-2600SBS-5, AR-2600SBS-7
Lot: 10078259, 10078258, 10072425, 10077133, 10078077, 10078340, 10075792, 10073992, 10072597, 10074288, 10074291, 10076753, 10076852, 10081420, 10075965, 10077252, 10084027, 10070003

MD: Ligament anchor

de

fr

en

Vk_20170411_05
24.04.2017 Friadent GmbH Dentsply

Implant Driver P EV 4.2 Long
Model 25465
Lot: 401290

MD: Driver/extractor

de

fr

en

Vk_20170413_10
24.04.2017 TORNIER SAS

611 Ankle Fusion Nail Drill
Model MJU777
Lot: 11 D463 und 12E794

MD: Drilling power tool attachment, basic

de

fr

Vk_20170413_17
24.04.2017 Siemens Healthcare Diagnostics Inc

Dimension TNI
Model RF621, 10464525
Lot: all

 

Dimension Vista DIGXN
Model K6435, 10488927
Lot: all

 

Dimension Vista E2
Model K6463, 10489099
Lot: all

 

Dimension Vista FERR
Model K6440, 10445136
Lot: all

 

Dimension Vista PRL
Model K6462, 10488398
Lot: all

 

Dimension Vista TSH
Model K6412, 10445104
Lot: all

IVD: Troponin I IVD; Digoxin therapeutic drug monitoring IVD; Estradiol (oestradiol) (E2) IVD; Ferritin IVD; Prolactin IVD; Thyroid stimulating hormone (TSH) IVD

de

fr

en

Vk_20170412_08
24.04.2017 Beckman Coulter, Inc.

Uric Acid
Model 442785
Lot: all

 

Enzymatic Creatinine
Model A60298
Lot: all

 

Cholesterol
Model 467825
Lot: all

 

HDL Cholesterol Reagent
Model A15625
Lot: all

 

Triglycerides Reagent
Model 445850
Lot: all

 

Salicylate Reagent
Model 378194
Lot: all

 

Lactate Reagent
Model A95550
Lot: all

IVD: Uric acid IVD; Creatinine IVD; Total cholesterol lipid IVD; High density lipoprotein (HDL) cholesterol IVD; Triglyceride IVD; Salicylate IVD; Total lactate dehydrogenase (LDH) IVD

de

fr

it

en

Vk_20170407_05
24.04.2017 Schwarzer Cardiotek GmbH

Schwarzer evo
Model schwarzer evoduo superior, schwarzer evoduo natal, schwarzer evoduo prime, 125452,125505,125508,125512,125600-615,125622-629
S/N: all

MD: Cardiac catheterization laboratory computer

en

Vk_20170413_20
24.04.2017 bioMérieux SA

eMAG system
Model 418591

IVD: Pipetting system

de

fr

en

Vk_20170413_23
24.04.2017 CardioTek B.V.

EP-TRACER
Model EP-TRACER 38, EP-TRACER 70, EP-TRACER 102
S/N: all
Software Version: V1.0x and V2.0.xxxx

MD: Cardiac electrophysiology analysis system

de

fr

it

en

Vk_20170413_21
24.04.2017 Medtronic Inc.

SynchroMed II
Model 8637-20, 8637-40
S/N: All pumps manufactured From March 2005 through December 2010 and pumps manufactured with the previous battery design from January 2011 through June 2011

AIMD: General-purpose implantable infusion pump, programmable

de

fr

it

en

Vk_20170413_12
24.04.2017 Miele and Cie. KG

PG 8527, PG 8528, PG 8535, PG 8536

MD: Disinfectors

de

fr

it

Vk_20170412_01
24.04.2017 RanD S.r.l

Hang&Go kits, HIPP(F)
Model R9900088, R9900067, R9900119, R9900033, R9900120
Lot: F160257, F170024, F160258, F170030, F170039, F170042, F170067, F170054, F160243, F170029, F170053

MD: Intravascular/intracavitary-circulation hyperthermia system set

en

Vk_20170418_06
24.04.2017 Beckman Coulter Ireland, Inc.

AQUIOS CL Cytometer
Model B30166
S/N: All
Software Version: 2.0 and 2.01

IVD: Flow cytometry analyser IVD, semi-automated

de

fr

en

Vk_20170418_05
24.04.2017 Samsung Electronics Co., Ltd

GC80
S/N: all

MD: Stationary basic diagnostic x-ray system, digital

de

fr

it

en

Vk_20170418_18
24.04.2017 Amplitude S.A.S.

Modular neck with taper 10/12
Model 1-0106701, 1-0106702, 1-0106703,1-0106704

 

Modular neck with taper 12/14
Model 1-0191001, 1-0191002, 1-0191003, 1-0191004

 

ACOR modular anatomic femoral stem

 

INTEGRALE modular femoral stem

 

OPTIMAL modular femoral stem

MD: Femoral head/stem prosthesis adaptor; modular anatomic femoral stem; modular femoral stem; modular femoral stem

de

fr

it

en

Vk_20170410_01
24.04.2017 Gambro Dasco S.p.A.

ARTIS 230V, EVOSYS 230V, ARTIS AFBK, ARTIS 230V Ph
Model 110635; 110648; 114389; 115323; 115324; 115326; 115401
S/N: All Artis machines equipped with software revision 8.09.12, 8.09.13, 8.15.06 and 8.33.02
Software Version: 8.09.12, 8.09.13, 8.15.06 and 8.33.02

MD: Haemodialysis system dialysate delivery unit

en

Vk_20170411_03
24.04.2017 DiaMed GmbH

Update

Lyra MP Reader II
Model 854002
Software Version: All

IVD: Blood grouping system, automated

de

de - Update

fr - Update

it - Update

en

en - Update

Vk_20150721_15