Інформація, отримана з іноземних систем повідомлення про продукцію, що становить серйозний ризик, за період 01.09.2020 – 31.10.2020

Опубліковано 01.11.2020 о 17:19

https://fsca.swissmedic.ch/mep/#/

30.10.2020 р.

Safersonic Medizinprodukte Handelsg.m.b.H.

Safersonic Regular Sterile Transducer Cover
Model: SAF.000.11070.CH
Lot: 9100890250, 9063890142, 9082190194

MD: Wrappers, Sterile

DE-1

Vk_20201030_07

21.10.2020 р.

(Updated 30.10.2020 р.)

Stereotaxis, Inc.

Niobe ES
Model: 3.2; 001-006000-1, 001-006100-1
S/N: see FSN
SW-Version: All

MD: Robotic surgical navigation system

DE-1
FR-1
IT-1
EN-1

Vk_20201013_08

22.10.2020 р.

(Updated 29.10.2020 р.)

Maquet Critical Care AB

FLOW-i
Model: 6887900; 6887700; 6888520; 6888530; 6888540
S/N: see FSN

MD: Anaesthesia workstation, general-purpose

DE-1
FR-1
EN-1

Vk_20201020_01

20.10.2020 р.

(Updated 29.10.2020 р.)

Medtronic Inc.

InterStim Percutaneous Extension
Model: 3560022, 3560030

MD: Neural-tissue electrical stimulation lead

DE-2
FR-2
IT-2
EN-1
EN-2

Vk_20201016_06

27.10.2020 р.

Sterisets Medical Products

Abdominal swab 45x45cm x-ray
Model: 56107S5D
Lot: 1909315

MD: Abdominal swab

EN-1

Vk_20201027_01

27.10.2020 р.

Corvia Medical, Inc.

InterAtrial Shunt Device (IASD) System II
Model: PN00261 IASD System II; 00435AW Rev 06 Instructions for Use

MD: atrial septal shunt implant

DE-1
FR-1
IT-1
EN-1

Vk_20201026_15

27.10.2020 р.

ViewRay Inc.

Stereotactic radiotherapy/MRI System
Model: MRIdian and MRIdian Linac System;10000, 20000
S/N: ALL
SW-Version: TPDS Versions 5.2.5 and 5.3

MD: Stereotactic teletherapy radionuclide system, MRI-imaging

EN-1

Vk_20201026_09

27.10.2020 р.

Karl Storz Endoskope SE und Co. KG

Plastic container for sterilizing
Model: 39402AS, 39406AS
Lot: all

MD: Sterilization/disinfection container

DE-1
FR-1
IT-1
EN-1

Vk_20201022_38

27.10.2020 р.

Mölnlycke Health Care AB

Single Packed Shielded Bladed Trocars
Model: see table of affected products
Lot: see table of affected products

Mölnlycke Procedure Trays
Model: see table of affected products
Lot: see table of affected products

MD: Laparoscopic access cannula, single-use

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

DE-1
EN-1

Vk_20201019_06

13.10.2020 р.

(Updated 27.10.2020 р.)

RaySearch Laboratories AB

RayStation
Model: see FSN
SW-Version: see FSN

MD: Radiation therapy software

DE-1
FR-1
IT-1
EN-1

Vk_20201008_22

26.10.2020 р.

MAQUET Cardiopulmonary GmbH

HCU40
Model: 70104.4054; 70105.4917;70104.4054; 70105.4917
Lot: N/A
S/N: All Serial Numbers below 90441922.
SW-Version: N/A

MD: Cardiopulmonary bypass system heat exchanger, reusable

DE-1
FR-1
EN-1

Vk_20201006_01

23.10.2020 р.

(Updated 23.10.2020 р.)

GE Medical Systems

Revolution CT
Model: see FSN
SW-Version: see FSN

MD: Full-body CT system

DE-1
FR-1
IT-1
EN-1

Vk_20201016_28

07.10.2020 р.

(Updated 23.10.2020 р.)

Leica Biosystems Newcastle Ltd

BOND Enzyme Pretreatment kit
Model: AR9551
Lot: All

IVD: Immunohistochemistry protease kit IVD

DE-1
FR-1
IT-1
EN-1

Vk_20201005_10

20.10.2020 р.

(Updated 22.10.2020 р.)

Willy Rüsch GmbH

Lasertube (Rubber) Laser resistant tracheal tube, cuffed; Endotracheal tube for laser surgery
Model: See FSN
Lot: See FSN

MD: Laser-resistant endotracheal tube

DE-1
FR-1
IT-1
EN-1

Vk_20201015_31

22.10.2020 р.

B.BRAUN MEDICAL

Actreen Hi-Lite Cath Nelaton
Model: 238312
Lot: 18H01E7SWD

Actreen Glys Set Nelaton
Model: 226314A
Lot: 17D28E8SAG

Actreen Mini Cath Nelaton
Model: 228012A
Lot: 18C01E7SWA

Urinocol Pädiatrie Girl geschlossen
Model: 227560A
Lot: 18F07E8SHB

MD: Urine-sampling urethral catheter

MD: Urine-sampling urethral catheter

MD: Urine-sampling urethral catheter

MD: Enteral feeding tube clearing kit

DE-1
FR-1
IT-1

Vk_20201012_15

14.10.2020 р.

(Updated 22.10.2020 р.)

bioMérieux SA

VIDAS FT4
Model: 30459
Lot: 1007821050

IVD: Free thyroxine (FT4) IVD, kit, enzyme immunoassay (EIA)

DE-1
FR-1
EN-1

Vk_20201012_07

12.10.2020 р.

(Updated 22.10.2020 р.)

Bühlmann Laboratories AG

BÜHLMANN GanglioCombi MAG ELISA
Lot: 4336, 3434, 4135, 3333, 2332.1

IVD: Ganglioside total antibody IVD, kit, enzyme immunoassay (EIA)

DE-1
FR-1
IT-1
EN-1

Vk_20201006_33

21.10.2020 р.

3M Health Care

3M Red Dot Monitoring Electrode
Model: 2228 and 2228BA
Lot: 202204LK, 202204LL, 202204LM, 202204LN, 202204LP, 202204LQ, 202204LR, 202204LS, 202204LX, 202204LZ, 202204MA; 202204BA, 202204BB, 202204BC, 202204BD, 202204BE, 202204BF, 202204BG, 202204BH, 202204BI, 202204BJ, 202204BK, 202204BL, 202204BM, 202204BN

MD: Electrocardiographic electrode, single-use

DE-1
EN-1

Vk_20201015_22

21.10.2020 р.

Paul Hartmann AG

CombiSet containing sterile hypodermic needle MEDOJECT
Model: See FSN
Lot: See FSN

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

DE-1
FR-1
IT-1

Vk_20201009_01

21.10.2020 р.

AREX

Mini external fixator – HK2
Model: HK2 1.2, HK2 1.5, HK2 1.8, HK2 1.2F, HK2 1.5F, HK21.8F
Lot: 12O366B, 15O365B, 18O359B, 12Q456C, 15P451C, 18P450C

MD: External orthopaedic fixation system, single-use, non-sterile

EN-1

Vk_20201002_13

14.10.2020 р.

(Updated 19.10.2020 р.)

Draeger Medical Systems, Inc.

Infinity Acute Care System
SW-Version: VG7.1

MD: General-purpose multi-parameter bedside monitor

DE-1
FR-1
IT-1
EN-1

Vk_20201009_10

19.10.2020 р.

Novocure GmbH

Optune
Model: TFH9100; TFH9100EU-Optune Commercial EU

MD: Alternating electric field antimitotic cancer treatment system generator

DE-1
FR-1
IT-1
EN-1

Vk_20201008_11

23.10.2019 р.

(Updated 16.10.2020 р.)

Medtronic Inc.

MyCareLink Heart Mobile Application
Model: MSW003, MSW004

CareLink Programmer
Model: 2090
S/N: all

29901 EncoreTM Programmer
Model: 29901
S/N: all

CareLink Network Application Software 2491
Model: 2491

CareLink SmartSync Device Manager
Model: 24967, 24970A
S/N: 24967, 24970A

AIMD: App for mobile devices

AIMD: Cardiac pulse generator programmer

AIMD: Cardiac pulse generator programmer

AIMD: Implantable cardiac device management application software

AIMD: Implantable pacemaker analyser, intraoperative

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_20191003_14

13.10.2020 р.

(Updated 15.10.2020 р.)

Integra LifeSciences Corp

Codman Bactiseal EVD Catheter
Model: 821750; 821749
Lot: 4451876; 4451880; 4451883; 4561693, 4451857 ; 4451858

MD: Intracerebral infusion/drainage catheter, short-term

FR-1-HOSPITAL
EN-1-DISTRIBUTOR
EN-1-HOSPITAL

Vk_20201008_14

13.10.2020 р.

(Updated 15.10.2020 р.)

HAAG-STREIT SURGICAL GmbH & Co. KG

Floor Stand FS 2-11
Model: 615H511
S/N: from SN 1001
SW-Version: 2.0 to 3.3 in combination with HS Hi-R NEO 900/A

Floor Stand FS 2-15
Model: 615H515
S/N: from SN 1001
SW-Version: 2.0 to 3.3 in combination with HS Hi-R NEO 900/A

MD: Surgical microscope system for opthalmology

MD: Surgical microscope system for opthalmology

DE-1
EN-1

Vk_20201006_08

14.10.2020 р.

Geistlich Pharma AG

Geistlich Bio-Oss Pen
Model: 30661.1, 30662.1, 30671.1
Lot: see FSN

MD: Dental bone matrix implant, animal-derived

DE-1
FR-1
IT-1
EN-1

Vk_20201012_01

14.10.2020 р.

Philips Healthcare (Invivo Corporation)

MRI system coil
Model: see FSN
Lot: see FSN

MD: MRI system coil, radio-frequency

DE-1
FR-1
IT-1
EN-1

Vk_20201009_17

14.10.2020 р.

Philips Medical Systems

Philips Internal Switched Paddles
Model: Switched M4741A, M4742A, M4743A, M4744A, ¿ Switchless M1741A, M1742A, M1743A, M1744A (Instructions for use);NA
Lot: NA
S/N: see UL86100222
SW-Version: NA

MD: DC-defibrillator, low-energy, (including paddles)

DE-1
FR-1
IT-1
EN-1

Vk_20201008_19

06.10.2020 р.

(Updated 14.10.2020 р.)

Stryker Neurovascular

Trevo Retriever
Model: see FSN
Lot: Please see attached in FSN

MD: Thrombectomy suction catheter

DE-1
FR-1
IT-1
EN-1

Vk_20201002_16

14.10.2020 р.

Karl Storz SE & Co.KG

KARL STORZ OR1 FUSION CONTROL
Model: WO300
S/N: all
SW-Version: 1.4.0 / 1.4.1

MD: Operating room audiovisual data/device management system application software

DE-1
FR-1
IT-1
EN-1

Vk_20200929_11

13.10.2020 р.

Renishaw Mayfield

Neuromate
S/N: All
SW-Version: v5.2 onwards

MD: Neurological stereotactic surgery system

DE-1
FR-1
EN-1

Vk_20201012_12

28.01.2020 р.

(Updated 13.10.2020 р.)

Roche Diagnostics GmbH

Elecsys CA 19-9
Model: 07027028190
Lot: see FSN

IVD: Cancer antigen 19-9 (CA19-9) IVD, kit, chemiluminescent immunoassay

DE-1
DE-2
DE-3
DE-4
DE-5
FR-1
FR-2
FR-3
FR-4
FR-5
IT-1
IT-2
IT-3
IT-4
IT-5
EN-1
EN-2
EN-3
EN-4
EN-5

Vk_20200124_20

12.10.2020 р.

Verathon Inc.

BladderScan Prime Plus Probe
Model: 0570-0395
S/N: P1517645; P1517657

MD: General-purpose ultrasound imaging system

DE-1
FR-1

Vk_20201001_08

01.10.2020 р.

(Updated 12.10.2020 р.)

Jotec GmbH

E-ventus BX Peripheral Stent Graft System
Model: All
Lot: All

MD: Stent, vascular

DE-1
FR-1
IT-1
EN-1

Vk_20200928_10

31.03.2020 р.

(Updated 12.10.2020 р.)

Respironics California, LLC

V60 Ventilator
Model: V60
Lot: NA
S/N: See fsn
SW-Version: 2.10 and 2.30

MD: Portable electric ventilator

DE-1
DE-2
DE-3
DE-4
FR-1
FR-2
FR-3
FR-4
EN-1
EN-2
EN-3
EN-4

Vk_20200330_04

08.09.2020 р.

(Updated 09.10.2020 р.)

ICU Medical, Inc.

31″ (78 cm) Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros, Bag Hanger
Model: 011-CL3011
Lot: 4867937, 4889630

Spinning Spiros Closed Male Luer, Red Cap
Model: CH2000S-C
Lot: 4749755, 4896004

MD: Neutral-pressure intravenous line needleless valve-connector

MD: Intravenous administration set

DE-1
DE-2
FR-1
FR-2
IT-1
IT-2

Vk_20200907_01

08.10.2020 р.

Bausch & Lomb Inc.

Dk-line
Model: VRL100, VRL110

Okta-line
Model: VRL200

MD: Retinal tamponade medium, intraoperative

MD: Retinal tamponade medium, intraoperative

DE-1
FR-1
IT-1
EN-1

Vk_20201002_18

07.10.2020 р.

Caire Inc.

Companion 1000 Liquid Oxygen Portable

MD: Liquid Oxygen System

DE-1
FR-1

Vk_20200910_23

06.10.2020 р.

Applied Medical Resources Corporation

BARD, Syntel
Model: A4FXX, A44XX and CE0XXXST; Catalogue Numbers: 100564601, 100564701, 100564801, 100564901,100565001, 100565101, 100565201, 100565301, 100565401, 100609601, 100609701, 100609801, 100609901, 100610001, 100610101, 100610201

MD: Thrombectomy balloon catheter

FR-1
EN-1

Vk_20201001_20

06.10.2020 р.

ACUTRONIC Medical Systems AG

fabian +nCPAP evolution
Model: 122001
S/N: All
SW-Version: 5.0.x, 5.1.x

Fabian HFO
Model: 111001, 111001.01, 112001, 113001
S/N: All
SW-Version: 5.0.x, 5.1.x

MD: Neonatal intensive-care ventilator

MD: Neonatal intensive-care ventilator

DE-1
FR-1
IT-1
EN-1

Vk_20201001_05

25.09.2020 р.

(Updated 05.10.2020 р.)

Stryker GmbH

Osteosynthesis Compression Staple EasyClip
Model: see FSN
Lot: all

EasyClip Xpress
Model: see FSN
Lot: all

MD: Orthopaedic bone staple, non-adjustable, non-sterile

MD: Orthopaedic bone staple, non-adjustable, non-sterile

DE-1
FR-1
IT-1
EN-1

Vk_20200924_08

05.10.2020 р.

Dräger Medical GmbH

Perseus A500
Model: MK06000
S/N: multipe
SW-Version: 2.03

MD: Anesthesia Units

DE-2
EN-2

Vk_20200911_09

23.09.2020 р.

(Updated 05.10.2020 р.)

Getinge – Maquet GmbH

OR-Table Meera
Model: see FSN
S/N: see FSN

OR-Table Yuno
Model: see FSN
S/N: see FSN

OR-Table Yuno II
Model: see FSN
S/N: see FSN

MD: Universal operating table, electrohydraulic

MD: Universal operating table, electrohydraulic

MD: Universal operating table, electrohydraulic

DE-1
FR-1
EN-1

Vk_20200910_24

02.10.2020 р.

Syntellix AG

MAGNEZIX CS
Model: 1027.014, 1032.014
Lot: 197553, 197557

MD: Screws, Bone

DE-1
EN-1

Vk_20200922_06

29.09.2020 р.

(Updated 01.10.2020 р.)

Siemens Healthcare Diagnostics Inc

ADVIA Centaur HBsAgII
Model: 10492138
Lot: see FSN
S/N: N/A

IVD: Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay

DE-1
EN-1

Vk_20200925_10

01.10.2020 р.

Boston Scientific (American Medical Systems Inc.)

AMS 700 with MS Pump Penile Prosthesis
Model: See Field Safety Notice (FSN);N/A
Lot: N/A
S/N: See Field Safety Notice (FSN)
SW-Version: N/A

MD: Inflatable penile prosthesis

DE-1
FR-1
EN-1

Vk_20200925_02

11.09.2020 р.

(Updated 01.10.2020 р.)

Paul Hartmann AG

Longuetten mit Röntgenkontrastfaden
Model: 2274908, 2274909
Lot: 099701000, 099601003, 099501006

Tela products
Model: 4511041, 4511091, 4521331, 4521352, 4521372, 4521452
Lot: 999302000, 999102006, 999202003, 099902001, 099402006

MD: Woven gauze pad, non-sterile

MD: Woven gauze pad, sterile

DE-1
DE-2
FR-1
FR-2
IT-1

Vk_20200908_01

11.09.2020 р.

(Updated 01.10.2020 р.)

Paul Hartmann AG

CombiSet containing Longuetten (X-Ray Gauze Swabs)

MD: Woven gauze pad, sterile

DE-1
DE-2
FR-1
FR-2

Vk_20200831_16

30.09.2020 р.

Fujifilm Corporation

FUJIFILM 580-U Series and 700 Series
Model: Model numbers: EC-760R-V/M, EC-760R-V/I, EC-760R-V/L, EC-760ZP-V/M, EC-760ZP-V/L, EG-760R, EG-760Z, EG-580UT, EG-580UR; Catalogue numbers: 16499851, 16499849, 16517615, 16517627, 16517603, 16517641, 16517639, 16517586, 16517598
S/N: See document Serial Numbers

MD: Flexible video duodenoscope, reusable

DE-1
FR-1
IT-1
EN-1
EN-Serial Numbers

Vk_20200924_21

27.07.2020 р.

(Updated 30.09.2020 р.)

Lohmann & Rauscher GmbH & Co. KG

Gauze swabs with x-ray thread in Kitpack, SetPack
Lot: Gauze compresses with X-ray contrast thread in different procedure packs (Kitpack) and as individual products (SetPack) – see FSN and list with additional lot no.

MD: Woven gauze pad, sterile

DE-1-KITPACK
DE-1-SETPACK
DE-KIT: List add. Lots
DE-SET: List add. Lots
FR-1-KITPACK
FR-1-SETPACK
IT-1-KITPACK
IT-1-SETPACK
IT-KIT: List add. Lots
IT-KIT: List add. Lots

Vk_20200721_04

30.09.2020 р.

Acotec Scientific Co, Ltd.

AcoArt Tulip (Former Brand Name: Tulip)
Model: all
Lot: all

AcoArt Litos (Former Brand Name: Litos)
Model: all
Lot: all

AcoArt Orchid (Former Brand Name: Orchid)
Model: all
Lot: all

MD: Peripheral angioplasty balloon catheter, drug-coated

MD: Peripheral angioplasty balloon catheter, drug-coated

MD: Peripheral angioplasty balloon catheter, drug-coated

DE-1
FR-1
IT-1
EN-1

Vk_20200623_07

28.09.2020 р.

Siemens Healthcare GmbH, Magnetic Resonance (MR)

ARTIS Icono Biplane
Model: 11327600

ARTIS pheno systems
Model: 10849000

ARTIS icono floor
Model: 11327700

MD: Stationary angiographic x-ray system, digital

MD: Stationary angiographic x-ray system, digital

MD: Stationary angiographic x-ray system, digital

DE-1

Vk_20200918_18

22.09.2020 р.

(Updated 25.09.2020 р.)

Olympus Medical Systems Corp.

EVIS EXERA Bronchovideoscope
Model: BF-XT160; N4499130, N4499340, N4499260, 020584, 6877930, 6877960
S/N: all

EVIS EXERA II BRONCHOVIDEOSCOPE
Model: BF-1T180; N3820860, N3630930, N3630960, N2117660, N3820830, N2117630
S/N: all

MD: Flexible video bronchoscope, reusable

MD: Flexible video bronchoscope, reusable

DE-1
FR-1
EN-1

Vk_20200917_05

25.09.2020 р.

Siemens Healthcare GmbH, Diagnostic Imaging, X-Ray-Products

Uroskop Omnia
Model: 10094910

Uroskop Omnia Max
Model: 10762473

MD: Stationary uro-gynaecological fluoroscopic x-ray system, digital

MD: Stationary uro-gynaecological fluoroscopic x-ray system, digital

DE-1

Vk_20200915_11

16.09.2020 р.

(Updated 25.09.2020 р.)

Olympus Medical Systems Corp.

OES CHOLEDOCHOFIBERSCOPE – OLYMPUS CHF TYPE CB30S
Model: CHF-CB30S; A5197, 1112283, 2000386, K23007046, N4499530
S/N: all

MD: Flexible fibreoptic choledochoscope

DE-1
EN-1

Vk_20200909_24

24.09.2020 р.

W.L. Gore&Associates, Inc.

Conformable GORE TAG Thoracic Endoprosthesis
Model: See attachment 1b
Lot: not specific to any particular lot or serial numbers; correction only, there will be no non-recalled or reintroduced product.

MD: Descending thoracic aorta endovascular stent-graft

DE-1
DE-1
IT-1
EN-1

Vk_20200911_11

24.09.2020 р.

W.L. Gore&Associates, Inc.

GORE TAG Conformable Thoracic Stent Graft
Model: See attachment 1b
Lot: not specific to any particular lot or serial numbers; correction only, there will be no non-recalled or reintroduced product.

MD: Descending thoracic aorta endovascular stent-graft

DE-1
FR-1
IT-1
EN-1

Vk_20200911_10

15.09.2020 р.

(Updated 24.09.2020 р.)

Teleflex Medical

Langston Dual Lumen Catheter
Model: 5515; 5540; 5545; 5550;
Lot: Refer to Appendix 2 of the FSN
S/N: n/a
SW-Version: n/a

MD: Angiographic catheter, single-use

DE-1
FR-1
EN-1

Vk_20200910_01

15.09.2020 р.

(Updated 24.09.2020 р.)

Micro Therapeutics, Inc.

Pipeline Flex Embolization Device & Pipeline Flex with Shield Technology
Model: all
Lot: all

MD: Bare-metal intracranial vascular stent

DE-1
FR-1
IT-1
EN-1

Vk_20200908_02

23.09.2020 р.

Symbios Orthopédie SA

FIRST Femur Cemented
Model: 5002 1021, 5002 1031 and 5002 1032
Lot: 1025491B+, 1077661-, 1096641-, 1121291-, 1122221-, P015493B-, P015714A-

MD: Uncoated knee femur prosthesis, metallic

FR-1
EN-1

Vk_20200918_10

23.09.2020 р.

Smith & Nephew, Inc.

Suture Based Repair Systems
Model: see FSN
Lot: see FSN

MD: Tendon/ligament bone anchor, bioabsorbable

DE-1
FR-1
IT-1
EN-1

Vk_20200918_01

23.09.2020 р.

Teleflex Malaysia

Rusch TracFlex Plus Phonation Set, Cuffed
Model: 121902-000070, 121902-000080, 121902-000090, 121902-000100, 121902-000110, 858002-000070, 858002-000080, 858002-000090, 858002-000100, 858002-000110
Lot: Reference FSN
S/N: NA
SW-Version: NA

Ruschcare TracFlex Plus Phonation Set, Cuffed

MD: Tracheostomy tube, non-reinforced, non-customized, single-use

MD: Tracheostomy tube, non-reinforced, non-customized, single-use

DE-1
FR-1
EN-1

Vk_20200916_33

23.09.2020 р.

Merit Medical Systems, Inc.

Prelude SNAP Splittable Sheath Introducer
Model: PLS-1006, PLS-1007, PLS-1008, PLS-1009, PLS-1010, PLS-2507, PLS-2509
Lot: see attached FSN

Worley Advanced Coronary Sinus Guide Splittable Introducer Kits and Worley Lateral Vein Introducer Splittable Sheaths
Model: WOR-CSG-B1-09, WOR-CSG-B2-09, WOR-CSG-BL1-09, WOR-CSG-E-90, WORLVI-75-5-62-07-RE, WORLVI-75-5-62-55-RE
Lot: see attached FSN

MD: Vascular catheter introduction set, nonimplantable

MD: Vascular catheter introduction set, nonimplantable

DE-1

Vk_20200916_01

21.09.2020 р.

(Updated 23.09.2020 р.)

Coloplast A/S

Elefant – Suction-irrigation device
Model: ASP145; ASP185
Lot: 7459530 (ASP 145); 7424848, 7440796, 7440801 (ASP185)

MD: Endoscope lens cleaner, gas/fluid, reusable

DE-1
FR-2

Vk_20200914_21

15.09.2020 р.

(Updated 23.09.2020 р.)

Olympus Medical Systems Corp.

SINGLE USE POWERSPIRAL TUBE DPST-1
Model: N5788540
Lot: all
S/N: all

INTESTINAL VIDEOSCOPE OLYMPUS PSF-1
Model: N5788540
Lot: all
S/N: all

MD: Flexible video enteroscope

MD: Flexible video enteroscope

DE-1
EN-1

Vk_20200909_25

07.07.2020 р.

(Updated 23.09.2020 р.)

Smith & Nephew, Inc.

T-FIX RCG Sterile Drill
Model: 014771
Lot: 2042492 for (R-2020-12), 2049408 for (R-2020-12 (R2))

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

DE-1
DE-2
FR-1
FR-2
IT-1
IT-2
EN-1
EN-2

Vk_20200703_10

22.09.2020 р.

Boston Scientific Corporation

Hurricane RX Dilatation Balloon
Model: M00545890, M00545900, M00545910, M00545920, M00545930, M00545940, M00545950, M00545960
Lot: See FSN
SW-Version: N/A

MD: Gastrointestinal/biliary dilation balloon catheter

DE-1
FR-1
EN-1

Vk_20200917_01

22.09.2020 р.

Brainlab AG

Ultrasound Navigation Software
Model: 22582; 22582A; 22582B; 22583; 26506; 26506A; 26508A
SW-Version: 1.0.x

Ultrasound Integration Software for Cranial/ENT Navigation
SW-Version: 3.0.x, 3.1.x

MD: Robotic surgical navigation system

MD: Robotic surgical navigation system

DE-1
FR-1
IT-1
EN-1

Vk_20200916_20

08.09.2020 р.

(Updated 18.09.2020 р.)

Cook Incorporated

Pediatric Nephrostomy Stent Set
Model: 080208-S6, 080208-S7
Lot: All

Percutaneous Neonatal Pigtail Nephrostomy Set
Model: 080106
Lot: All

MD: Nephrostomy catheter

MD: Nephrostomy catheter

DE-1
DE-2
FR-1
FR-2
IT-1
IT-2

Vk_20200902_12

17.12.2019 р.

(Updated 17.09.2020 р.)

Intuitive Surgical, Inc

Endoscope and Camera Head Sterilization Tray
Model: 400498-02, 400499-03; 8mm
Lot: all

MD: Instrument tray

DE-1
DE-2
FR-1
IT-1
IT-2
EN-1
EN-2

Vk_20191213_10

16.09.2020 р.

Gesellschaft für Homecare und Medizintechnik GmbH

AEROtube Endotrachealtubus-SET
Model: see FSN
Lot: all

MD: Endotracheal Tubes

DE-1
EN-1

Vk_20200911_22

15.09.2020 р.

Blink Medical

Liposuction Cannula
Model: see FSN
Lot: see FSN

MD: Liposuction system cannula, reusable

DE-1
EN-1

Vk_20200911_03

08.09.2020 р.

(Updated 15.09.2020 р.)

LAMIDEY NOURY MEDICAL

Bipolar cutting loop 2.5mm GY
Model: VRUG25
Lot: 2016-1, 2030-5
S/N: N/A
SW-Version: N/A

MD: Electrosurgical diathermy system electrode, active, single-use

DE-1
FR-1
IT-1
EN-1

Vk_20200902_11

01.09.2020 р.

(Updated 15.09.2020 р.)

Fresenius Medical Care AG & Co. KGaA

AquaC UNO H
Model: F00002272, F00003544, F00003546, F00004565
S/N: Please see the list included in the FSN

MD: Reverse-osmosis water purification system

DE-1
EN-1

Vk_20200827_01

20.08.2020 р.

(Updated 15.09.2020 р.)

AREX

LIGAMENTOTAXOR / LTX

MD: External orthopaedic fixation system, single-use, sterile

DE-1
FR-1
IT-1
EN-1

Vk_20200804_04

14.09.2020 р.

Dako North America, Inc.

Autostainer Link 48/Plus/Classic
Model: AS480; AS100; S3800; S3400;AS480
Lot: N.A.
S/N: Please see appendix: List of Affected Instruments and Customers

IVD: Microscope slide stainer IVD

DE-1
FR-1
IT-1
EN-1

Vk_20200901_07

14.09.2020 р.

PTW-Freiburg

Software VeriSoft
Model: S080032
SW-Version: 8.0 (S070009)

Software BeamAdjust
Model: S070009
SW-Version: 2.2 (S080032)

MD: Ionization chamber radiation measuring probe

MD: Ionization chamber radiation measuring probe

DE-1
FR-1
IT-1
EN-1

Vk_20200827_08

05.08.2020 р.

(Updated 14.09.2020 р.)

Siemens Healthcare Diagnostics Inc

Dimension EXL High Sensitivity Troponin I Flex
Model: 10471068
Lot: EB0255

Dimension Vista High Sensitivity Troponin I Flex
Model: 10471067
Lot: 20008BB, 20035BC, 20135BB

IVD: Troponin I IVD, kit, chemiluminescent immunoassay

IVD: Troponin I IVD, kit, chemiluminescent immunoassay

DE-1
DE-2
FR-1
FR-2
EN-1
EN-2

Vk_20200730_06

22.07.2020 р.

(Updated 14.09.2020 р.)

Life Technologies Corporation, a part of Thermo Fisher Scientific

TaqPath COVID-19 CE-IVD RT-PCR kit

Applied Biosystems – COVID-19 Interpretive Software
Model: 100093771: v1.2; 100094143: v2.1; 100094318: v2.2
Lot: n/a
S/N: n/a
SW-Version: 1.2, 2.1, 2.2

IVD: SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)

IVD: SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)

DE-1
DE-2
FR-1
FR-2
IT-1
IT-2
EN-1
EN-2

Vk_20200720_03

16.06.2020 р.

(Updated 14.09.2020 р.)

Siemens Healthcare Diagnostics Inc

Chemistry Calibrator
Model: 10312279, 09784096; 11099411
Lot: 534177, 534177A, 534177B, 534177C, 534177D, 960742; 534179, 534179A, 534179B, 534179C, 534179D, 534179E, 911591, 911591A, 911591B, 911591C
S/N: N/A
SW-Version: N/A

IVD: Multiple clinical chemistry analyte IVD, calibrator

DE-2 (ADVIA Chemistry)
DE-2 (Atellica CH)
DE-4 (ADVIA Chemistry)
DE-4 (Atellica

 

22.01.2020 р.

(Updated 14.09.2020 р.)

Philips Medical Systems Nederland BV

Integris CV, Allura CV
Model: See FSN

Allura Xper
Model: See FSN

OmniDiagnost Eleva
Model: See FSN

MultiDiagnost Eleva with Flat Detector
Model: See FSN

Allura Centron
Model: See FSN

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

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

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

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

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

DE-1
DE-2
FR-1
FR-2
IT-1
IT-2
EN-1
EN-2

Vk_20200120_01

11.09.2020 р.

Medtronic Inc.

Rashkind® Balloon Septostomy Catheters
Model: 007160, 007161, 008764
Lot: See FSN

MD: Cardiac septostomy catheter, balloon

DE-1
EN-1

Vk_20200826_23

11.09.2020 р.

Ad-Tech Medical Instrument Corporation

Drill Sleeve Guide
Model: N/A;DSG-90-2.3N; DSG-6.3-090-2.4N
Lot: See attached
S/N: N/A
SW-Version: N/A

MD: Surgical drill guide, reusable

DE-1
FR-1
EN-1

Vk_20200805_01

09.09.2020 р.

Phoenix s.r.l

Arcomed Volumed-Set
Model: AS-APPPK0J-BV
Lot: 20PH023

MD: Infusion set

DE-1

Vk_20200903_22

09.09.2020 р.

Mentor Texas LP

MENTOR Breast Tissue Expander
Model: CPX4
Lot: All Lots

MD: Skin-port tissue expander

DE-1
FR-1
IT-1

Vk_20200827_22

08.09.2020 р.

intra special catheters GmbH

Pneumocath
Model: see FSN
Lot: see FSN

Neo-Pneumocath
Model: see FSN
Lot: see FSN

Thoracath
Model: see FSN
Lot: see FSN

MD: Drains, Thoracic

MD: Drains, Thoracic

MD: Drains, Thoracic

DE-1
FR-1
IT-1
EN-1

Vk_20200904_15

08.09.2020 р.

Siemens Medical Solutions USA, Inc.

Symbia S and T Series camera systems
Model: 8717741, 8717733, 10275007, 10275008, 10275009, 10275010

MD: Stationary gamma camera system

EN-1

Vk_20200904_01

08.09.2020 р.

Sysmex Corporation Japan

Sysmex Automated Blood Coagulation Analyzer
Model: CN-6000, CN-3000, CS-5100, CS-2000i, CS-2100i, CS-2400, CS-2500, CS-1600, CS-1300, CA-510, CA-520, CA-530, CA-540, CA-550, CA-560, CA-620, CA-650, CA-660, CA-1500, CA-7000, CA-8000
S/N: all

IVD: 23-04-03

DE-1
FR-1

Vk_20200902_13

08.09.2020 р.

GE Medical Systems Israel, Functional Imaging

Discovery NM 630

Discovery NM/CT 670

NM 830

NM/CT 860

NM/CT 850

NM/CT 870

MD: Stationary gamma camera system

MD: Full-body CT system

MD: Stationary gamma camera system

MD: Full-body CT system

MD: Full-body CT system

MD: Full-body CT system

DE-1
FR-1
IT-1
EN-1

Vk_20200902_04

08.09.2020 р.

Abbott GmbH & Co. KG

ARCHITECT Galectin-3 Reagent
Model: 5P03-25
Lot: 10037M800

IVD: Galectin-3 IVD, kit, chemiluminescent immunoassay

DE-1
EN-1

Vk_20200901_01

08.09.2020 р.

Ventana Medical Systems Inc

BENCHMARK ULTRA STAINER MODULE
Model: 05342716001
SW-Version: n/a

IVD: Microscope slide stainer IVD

DE-1
FR-1
EN-1

Vk_20200831_17

07.09.2020 р.

Allmed Medical Products Co., Ltd.

X-Ray Gauze Swabs
Model: AL002XR, AL004XRA-Bulk, AL005XR, AL006XR, AL007XR, AL008XR, AL017XR, AL021XR, AL026XR

MD: Swab

DE-1
FR-1
IT-1
EN-1

Vk_20200831_14

02.09.2020 р.

(Updated 07.09.2020 р.)

Pall Medical – A Division of Pall International Sàrl

Pall Breathing System Filter
Model: BB50TES
Lot: 20-1153

MD: Microbial medical gas filter, sterile, reusable

DE-1
EN-1

Vk_20200825_06

04.09.2020 р.

Pearl Technology AG

ProBelt 200 R2, ProBelt 200 R3, ProBelt 200 T5
Model: 1170-A, 1171-A, 1172-A
Lot: 20070013, 20070014, 20070015, 20070031, 20070032, 20080010

MD: Radiological general body-part positioner

DE-1

Vk_20200902_01

21.08.2020 р.

(Updated 03.09.2020 р.)

Nouvag AG

DP30 LipoPlus
Model: 4161, 4163
S/N: 4621U1904R, 7881U1901R, 4610U1904R, 4611U1904R, 1180U1908R, 7878U1901R, 7897U1901R, 7898U1901R, 1193U1908R, 7892U1901R

MD: General-purpose infusion pump, line-powered

DE-1
FR-1
EN-1

Vk_20200817_01

21.08.2020 р.

(Updated 03.09.2020 р.)

Nouvag AG

MD11, MD30
S/N: 0658U1902R, 6974U1912R, 5906U1811R, 5942U1811R, 0656U1902R, 6956U1912R, 6967U1912R, 2405U1803R, 2411U1803R, 1228U1908R, 9163U1901R

MD: Remotely-driven dental drilling system motor

DE-1
FR-1
EN-1

Vk_20200814_11

02.09.2020 р.

BEACON MEDICAL LLC

Beacon Chest Seal
Model: BCS-92592
Lot: W731

MD: Pneumothorax dressing

DE-1
FR-1

Vk_20200901_20

02.09.2020 р.

Siemens Healthcare GmbH

syngo.via RT Image Suite
Model: 10496180 and other
SW-Version: Several

MD: CT system application software

DE-1
EN-1

Vk_20200825_04

01.09.2020 р.

Allmed Medical Products Co., Ltd.

X-Ray Gauze Swabs
Model: KER70289, KER70290, KER70295, KER70167A, KER70150B, KER70151B, KER70180, KER70188A, KER70327
Lot: 166346, 169023, 172350, 166990,167260, 168292, 179057, 174264, 176539, 177752, 166452, 171699, 176385, 161083, 163562, 167587, 170655, 174795, 161115, 166327, 171690, 174457, 169016, 161232, 166420, 168808, 172615, 177025, 178946

MD: Swab

DE-1
EN-1

Vk_20200831_06

01.09.2020 р.

Siemens Healthcare Diagnostics Inc

Alkaline Phosphatase (ALPI) Flex reagent cartridge
Model: K2115; 10642444
Lot: 19247AB; 19282BB; 19330BD
S/N: N/A
SW-Version: N/A

IVD: Total alkaline phosphatase (ALP) IVD, kit, enzyme spectrophotometry

EN-1

Vk_20200828_17

01.09.2020 р.

FUJIFILM Medical System USA, Inc.

Fujifilm Synapse PACS
SW-Version: 5.5, 5.7.0 and 5.7.1

MD: Radiology PACS software

DE-1
EN-1

Vk_20200826_20

01.09.2020 р.

Siemens Healthcare GmbH, HC SV DS,

Artis Q

Artis Zee

MD: Stationary angiographic x-ray system, digital

MD: Stationary angiographic x-ray system, digital

DE-1
FR-1
EN-1

Vk_20200825_10

 

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