Інформація, отримана з іноземних систем повідомлення про продукцію, що становить серйозний ризик, за період 01.01.2024 – 31.03.2024 Швейцарія

(Updated )

Tecres S.p.A.

MectaCem-X HV with gentamicin
Model: 65.01.111
Lot: 23TC0019, 23TC0020, 23TC0021, 23TC0025, 23TC0026, 23TC0030, 23TC0033, 23TC0035

MectaCem-X LV mit Gentamicin
Model: 65.01.113
Lot: 23TC0027

MD: Orthopaedic Prostheses Cements And Accessories For Mixing

MD: Orthopaedic Prostheses Cements And Accessories For Mixing

DE-1
FR-1
IT-1

Vk_20240315_05

(Updated )

Randox Laboratories Ltd

CALIBRATION SERUM LEVEL 3 (CAL 3)
Model: CAL2351; CAL10388
Lot: 1260UE, 1262UE, 1295UE, 1297UE, 1298UE, 1315UE, 1325UE, 1326UE; 1295UE, 1325UE

IVD: Multiple-type clinical chemistry analyte profile IVD, calibrator

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

Vk_20240315_19

(Updated )

Philips Respironics, Inc

Trilogy Evo
Model: all Models

Trilogy Evo O2
Model: all Models

Trilogy EV300
Model: all Models

MD: Portable electric ventilator

MD: Portable electric ventilator

MD: Portable electric ventilator

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

Vk_20240310_03

(Updated )

Philips Medical Systems

Care Event
Model: 866435, 866436

Patient Information Center iX
Model: 866389, 866390, 866424

MD: Hospital-administration information system

MD: Centralized patient monitor

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

Vk_20240308_21

(Updated )

DH Healthcare GmbH

ORBIS Medication 3.x
SW-Version: 03.07.00.00

MD: General Medicine Instruments – Other

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

Vk_20240227_21

Philips Respironics, Inc

OmniLab Advanced +
Model: Please refer to Device Affected List; NA
Lot: NA
S/N: Please refer to Device Affected List

MD: Ventilator

EN-1

Vk_20240327_15

Atrium Medical Corporation

Ocean, Oasis and Express Chest Drains
Model: 2002-000, 2002-040, 2002-100, 2002-300, 2002-400, 2012-320, 2050-000, 3600-100, 3612-100, 3650-100, 4000-100N, 4050-100N
Lot: All product within expiry for listed Part Numbers

MD: Thoracic suction collection container

DE-1
FR-1
IT-1

Vk_20240319_45

(Updated )

Exactech Inc.

Exactech Equinoxe Shoulder UHMWPE
Model: see FSN
Lot: see FSN

MD: Shoulder glenoid fossa prosthesis, prefabricated

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

Vk_20240318_05

(Updated )

Abbott Molecular Inc.

Alinity m System
Model: 08N53-002
S/N: all

IVD: Nucleic Acid Testing Integreted Extration /amplification /detection Systems

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

Vk_20240322_01

(Updated )

Qiagen GmbH

EZ2 Connect MDx
Model: 9003230

IVD: Specimen processing instrument IVD

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

Vk_20240313_11

Thoratec Corporation

Heartmate III
Model: 106524INT
S/N: All serial numbers

AIMD: Implantable ventricular circulatory assist system

DE-1
FR-1
EN-1

Vk_20240320_01

Coloplast A/S

Ureteral Dilator (Ch/Fr 12-14, length 48 cm)
Model: RBD014
Lot: See FSN

MD: Endoscopic-access dilator, single-use

DE-1
FR-1
IT-1

Vk_20240321_01

Smiths Medical ASD, Inc.

CADD-Solis Ambulatory Infusion Pump
Model: See FSN
SW-Version: See FSN

MD: Bedside infusion pump, single-channel

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

Vk_20240325_26

Medtronic Inc.

DLP Tourniquet Kit
Model: See attachment A of FSN
Lot: See attachment A of FSN

Elongated One Piece Arterial Cannula
Model: See attachment A of FSN
Lot: See attachment A of FSN

Clearview Intracoronary Shunt
Model: See attachment A of FSN
Lot: See attachment A of FSN

Clearview Blower/Mister
Model: See attachment A of FSN
Lot: See attachment A of FSN

DLP Arterial Cannula
Model: See attachment A of FSN
Lot: See attachment A of FSN

Select Series Arterial Cannula
Model: See attachment A of FSN
Lot: See attachment A of FSN

DLP Heart Vent Catheter
Model: See attachment A of FSN
Lot: See attachment A of FSN

DLP Sump
Model: See attachment A of FSN
Lot: See attachment A of FSN

VC2 Venous Cannulae
Model: See attachment A of FSN
Lot: See attachment A of FSN

DLP Single Stage Venous Cannulae
Model: See attachment A of FSN
Lot: See attachment A of FSN

MC2 Two Stage Venous Cannulae
Model: See attachment A of FSN
Lot: See attachment A of FSN

DLP Cannula
Model: See attachment A of FSN
Lot: See attachment A of FSN

DLP Suction Tube
Model: See attachment A of FSN
Lot: See attachment A of FSN

DLP Disposable Pressure Display Set
Model: See attachment A of FSN
Lot: See attachment A of FSN

DLP Perfusion Cannula
Model: See attachment A of FSN
Lot: See attachment A of FSN

DLP Disposable Pressure Display Set
Model: See attachment A of FSN
Lot: See attachment A of FSN

DLP Needle
Model: See attachment A of FSN
Lot: See attachment A of FSN

DLP Adapter
Model: See attachment A of FSN
Lot: See attachment A of FSN

DLP Aortic Root Cannula
Model: See attachment A of FSN
Lot: See attachment A of FSN

MiAR Cannulae
Model: See attachment A of FSN
Lot: See attachment A of FSN

DLP Multiple Perfusion Set
Model: See attachment A of FSN
Lot: See attachment A of FSN

MD: Intravascular extraction catheter-snare

MD: Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, arterial

MD: Arteriovenous shunt

MD: Surgical mist irrigation tip

MD: Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, arterial

MD: Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, arterial

MD: Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, arterial

MD: Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, arterial

MD: Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, venous

MD: Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, venous

MD: Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, venous

MD: Coronary artery perfusion catheter

MD: Suction system catheter, general-purpose

MD: Cardiopulmonary bypass system blood tubing set

MD: Coronary sinus cannula

MD: Patient monitoring system module, blood pressure, invasive

MD: Cardioplegia cannula

MD: Cardioplegia solution administration adaptor

MD: Cardioplegia cannula

MD: Cardioplegia cannula

MD: Cardioplegia solution administration adaptor

DE-1

Vk_20240319_04

Fritz Stephan GmbH

Eve In
S/N: Only devices that have been updated to software version EVE Mainboard V2.8.0 by the service department in the field and have not passed the outgoing goods inspection at the factory.
SW-Version: EVE Mainboard V2.8.0 / EVE Service Software V2.2.4

Eve Tr
SW-Version: EVE Mainboard V2.8.0 / EVE Service Software V2.2.4

Eve Neo
SW-Version: EVE Mainboard V2.8.0 / EVE Service Software V2.2.4

MD: Adult And Paediatric/neonatal Pulmonary Ventilators

MD: Adult And Paediatric/neonatal Pulmonary Ventilators

MD: Adult And Paediatric/neonatal Pulmonary Ventilators

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

Vk_20240325_11

Oriplast GmbH

Schleimabsauger, 450mm, TA Ch.12, für Neugeborene
Model: VK00941

MD: UMDNS=12-648

DE-1
FR-1
IT-1

Vk_20240320_13

(Updated )

MAQUET Cardiopulmonary GmbH

HLS Set Advanced 5.0
Model: 701069073, 701069076
Lot: See Annex I of FSN

MD: Cardiopulmonary bypass system blood tubing set

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

Vk_20231222_13

Advanced Instruments LLC

OsmoPRO MAX Automated Osmometer
Model: OsmoPRO MAX
Lot: N/A
S/N: 23010060A, 23010061A
SW-Version: 1.5.0.0

IVD: Osmometers

DE-1
EN-1

Vk_20240318_06

(Updated )

Synthes GmbH

TFNA Femoral Nail
Model: 04.037.944S, 04.037.144S, 04.037.112S, 04.037.945S
Lot: 3744P37, H861026 // 4489P98 // 447P160 // H861035, H861036, H861037

VA-LCP Clavicle Plate
Model: 02.112.621S
Lot: 1201P12

Opal Intervertebral Cage
Model: 08.803.231S
Lot: 427P153

MD: Femur nail

MD: Femur nail

MD: Femur nail

DE-1
EN-1

Vk_20240205_13

NRT Xray A/S

Celex and Intelli-C EU
Model: see FSN
S/N: see FSN

MD: Stationary angiographic x-ray system, digital

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

Vk_20240322_25

Boston Scientific Corporation

Expo 5F Angiographic Catheters
Model: See FSN
Lot: See FSN
S/N: See FSN
SW-Version: NA

MD: Angiographic catheter, single-use

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

Vk_20240321_26

(Updated )

Intuitive Surgical, Inc

Instrument Arm Drape
Model: 470015-07
Lot: DM2214502

SureForm 45
Model: 480445-04
Lot: T91220125

SureForm 60
Model: 480460-09
Lot: T90220121

Cannula Seal
Model: 470361-08
Lot: M10211113

Bladeless Obturator
Model: 420023-03
Lot: 73J2100936

MD: Medical equipment drape, single-use

MD: Robotic surgical cutting stapler, single-use

MD: Robotic surgical cutting stapler, single-use

MD: Laparoscopic access cannula seal, single-use

MD: Endotherapy trocar, single-use

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

Vk_20240305_03

MicroPort CRM S.r.l.

XFINE
Model: XFine JX24D MRI, XFine JX25D MRI, XFine TX25D MRI, XFine TX26D MRI; TLD056C, TLD057C, TLD054C, TLD055C

AIMD: Endocardial pacing lead

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

Vk_20240322_07

Cipher Surgical Ltd

OpClear Disposable Procedure Kit
Model: CS-10-00-315, CS-10-30-315, CS-10-00-330, CS-10-30-330
Lot: A48/3/0041/22E, A02/4/0041/23E, A18/6/0041/23E, A11/6/0041/23F, A38/4/0041/22F, A05/5/0041/23F, A15/3/0041/23G, A09/3/0041/23H, A50/6/0041/22H

MD: Lens Cleaning Units

DE-1
EN-1

Vk_20240313_29

(Updated )

DiaMed GmbH

LISS/Coombs
Model: see FSN
Lot: all lots currently in use and future lots until further notice

Coombs Anti-IgG
Model: see FSN
Lot: all lots currently in use and future lots until further notice

ID-Diacell I-II-III
Model: see FSN
Lot: all lots currently in use and future lots until further notice

ID-DiaCell I-II-III Asia
Model: see FSN
Lot: all lots currently in use and future lots until further notice

IVD: Polyspecific antihuman globulin/complement IVD, antibody

IVD: Polyspecific antihuman globulin/complement IVD, antibody

IVD: Antibody screening reagent red blood cell IVD, kit, agglutination

IVD: Antibody screening reagent red blood cell IVD, kit, agglutination

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

Vk_20240310_15

DH Healthcare GmbH

ORBIS Medication 3.x
SW-Version: 03.15.00.00

MD: General Medicine Instruments – Other

DE-1
EN-1

Vk_20240220_20

(Updated )

Datascope Corp.

Intra-aortic Balloon Catheter
Model: see attachment-with descriptions; same as model number
Lot: see FSN
S/N: Device not serialized
SW-Version: N/A

MD: Intra-aortic balloon catheter

DE-1
FR-1
IT-1

Vk_20240214_36

(Updated )

Miltenyi Biotec B.V. & Co. KG

CliniMACS Prodigy
Model: 200-073-602
SW-Version: LP-TCRab-19 Depletion V2.1.12

MD: Magnetic cell separation system tubing set

DE-1
EN-1

Vk_20240313_02

Randox Laboratories Ltd

LIQUID PROTEIN CALIBRATORS (SP CAL (LIQ))
Model: IT2691
Lot: see FSN

IVD: Multiple clinical chemistry protein IVD, calibrator

EN-1

Vk_20240314_21

Andratec GmbH

AltoSa-XL-Gemini Balloon Catheter
Lot: 385661, 385645, 385646, 385663, 385661

MD: Peripheral angioplasty balloon catheter, basic

DE-1
EN-1

Vk_20240320_19

Medivance, Inc.

Neonatal ArcticGel Pads
Model: 318-02, 318-02-02
Lot: See FSN

MD: Body Temperature Measurement Devices

DE-1

Vk_20240215_22

Covidien llc

HUGO RAS Surgeon Console
Model: MRASC0001
S/N: see FSN

MD: Robot-assisted Endoscopic Surgery Systems

DE-1
EN-1

Vk_20240320_16

Covidien llc

HUGO RAS Tower (240VAC)
Model: MRASC0003 (Hugo RAS Tower 120VAC), MRASC0005 (Hugo¿ RAS Tower 240VAC)
S/N: see FSN

MD: Robot-assisted Endoscopic Surgery Systems

DE-1
EN-1

Vk_20240320_15

Siemens Healthcare Diagnostics Inc.

Atellica CH Iron3
Model: 11537211
Lot: All lots
S/N: N/A

IVD: Iron IVD, kit, spectrophotometry

DE-1
FR-1

Vk_20240318_01

XENIOS AG

Xenios Console
Model: 38350044, 38350050, 38350391, MEMDC0022, F30000163
S/N: 38350044: XCON0170 to XCON1073, 38350050: XECON0208 to XECON0340, 38350391: XCON0001 to XCON0047, MEMDC0022: MDCON0355 to MDCON0524, F30000163: XCONUS0001 to XCONUS0124

MD: Cardiopulmonary bypass system centrifugal pump drive unit

DE-1

Vk_20240313_08

(Updated )

Synovis Life Technologies, Inc. (a subsidiary of Baxter International Inc.)

PERI-GUARD
Model: PC0404SN, PC0608SN, PC0814N, PC0814SN, PC1016SN, PC1225N, Further codes not applicable to CH: PC0404N, PC0608N, PC1016N
Lot: All lots within expiry

MD: Extra-gynaecological surgical mesh, collagen, non-bioabsorbable

DE-1
FR-1
IT-1

Vk_20240229_34

Philips Electronics Nederland B.V.

Philips MR systems
Model: siehe FSN

MD: Full-body MRI system, superconducting magnet

EN-1

Vk_20240315_21

Olympus Medical Systems Corp.

HIGH FLOW INSUFFLATION UNIT
Model: UHI-4; N3829650, N3829660, N3829670
S/N: All

MD: Laparoscopic insufflator

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

Vk_20240319_02

DH Healthcare GmbH

ORBIS Medication 3.x

MD: General Medicine Instruments – Other

DE-1
EN-1

Vk_20240314_23

(Updated )

ResMed PTY LTD

Astral 100, Astral 150
Model: 27033 (Model: 100, 150)
S/N: 20142483483 – 22191006942

MD: Portable electric ventilator

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

Vk_20230912_01

Vyaire Medical GmbH

Twin Tube and Twin Tube Probenschlauch
Model: V-707327; 707004; V-707327; 707004
Lot: All units prior to June 2023
S/N: All units prior to June 2023

MD: Cardiopulmonary stress exercise monitoring system

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

Vk_20240311_18

(Updated )

Abiomed Inc.

Impella CP
Model: 0048-0008; 0048-0002

Impella 5.5 SmartAssist Heart Pump
Model: 0550-0007, 2000193; 0550-0002, 1000482

Impella 5.0 Heart Pump
Model: 0046-3114; 005060

Impella CP SmartAssist
Model: 2000154; 0048-0014

Impella 2.5
Model: 0046-3061; 005040

Impella RP
Model: 0046-3107; 0046-0011

Impella LD
Model: 004681; 005080

MD: Intracardiac circulatory assist axial-pump catheter

MD: Intracardiac circulatory assist axial-pump catheter

MD: Intracardiac circulatory assist axial-pump catheter

MD: Intracardiac circulatory assist axial-pump catheter

MD: Intracardiac circulatory assist axial-pump catheter

MD: Intracardiac circulatory assist axial-pump catheter

MD: Intracardiac circulatory assist axial-pump catheter

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

Vk_20240220_02

(Updated )

Life Technologies Holdings Pte Ltd

Ion PGM Dx Instrument System
Model: A52422
S/N: 5.12.5 ; 5.8 ; 5.6.4
SW-Version: 5.12.5 ; 5.8 ; 5.6.4

IVD: Laboratory instrument/analyser application software IVD

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

Vk_20240306_07

EVOLUTIS SAS

Femoral stems
Model: 01-021-01-0007, 01-021-01-0008, 01-021-03-0009, 1-0107807, 1-0107808, 1-0108209, H45 007, H45 008, H45 C007, H45 C008, H45 L009, H45 LC009, H45 R112XL, H45 S009, H45 SL009, H45 SL010, H49 007, H49 008, H49 S09, H73 007, H73 008, H73 C008
Lot: All batches

MD: GMDN=34191/34203/40125

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

Vk_20240215_02

Elekta Instrument AB

Disposable Biopsy Needle Kit – Leksell Neurosurgical Instruments
Model: 911933
Lot: 837838839

MD: Neurological stereotactic surgery system

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

Vk_20240306_20

(Updated )

ConvaTec Limited

CarboFlex
Model: 403203 & 403204
Lot: 3J02333, 3L04810, 3J00675, 3J02320, 3J02332, 3L04811 &, 4A00343

MD: Odour-absorbent dressing, non-antimicrobial

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

Vk_20240301_03

(Updated )

Medartis AG

2.5ADAPTIVE II TriLock DistRad.pl, pal li
Model: A-4750.105, A-4750.106, A-4750.124, A-4750.124TP
Lot: 23371369, 23371373, 23364417, 23348819

MD: Orthopaedic fixation plate, non-bioabsorbable

DE-1
DE-2
EN-1

Vk_20240216_33

Medtronic Inc.

Abre Venous Self-expanding Stent System
Model: AB9G14100090
Lot: B460542
S/N: N/A
SW-Version: N/A

MD: Vascular Stents

DE-1

Vk_20240306_06

Olympus Europa SE & Co. KG

Single Use Electrosurgical Knife
Model: KD-645L, KD-640L; N5412530, N2119630
Lot: all

MD: Endoscopic electrosurgical handpiece/electrode, monopolar, single-use

DE-1
FR-1
EN-1

Vk_20240307_30

Coris BioConcept

RESIST ACINETO
Model: K-15R13
Lot: 50485K2321, 50102I2305

IVD: Targeted Resistance Tests – Carbapenemase

DE-1
FR-1
IT-1

Vk_20240311_02

(Updated )

Instrumentation Laboratory Co.

ACL TOP Family 50 Series
Model: 00000280045, 00000280055, 00000280065, 00000280015, 00000280035
S/N: All with software v6.3.0 or later

ACL TOP 970 CL
Model: 00000280097
S/N: All with software 1.1.0

IVD: Coagulation analyser IVD, laboratory

IVD: Coagulation analyser IVD, laboratory

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

Vk_20240221_15

(Updated )

EKF-diagnostic GmbH

Quo-Lab A1c Test Kit
Model: 0055
Lot: 026246 to 026403, with expiry dates ranging from already expired to 2025-02-08

IVD: Glycated haemoglobin (HbA1c) IVD, reagent

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

Vk_20240305_02

(Updated )

Randox Laboratories Ltd

Randox Cystatin C Calibrator
Model: CYS2699
Lot: see FSN

IVD: Cystatin C IVD, calibrator

FR-1
EN-1

Vk_20240226_28

(Updated )

RaySearch Laboratories AB (publ)

RayStation
Model: 8B, 9A, 9B, 10A, 10B, 11A, 11B, 12A, 12B, 2023B, 2024A
S/N: see FSN

MD: Various Radiotherapy And Radiosurgery Instruments – Software Accessories

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

Vk_20240227_22

Synovis Life Technologies, Inc. (a subsidiary of Baxter International Inc.)

PERI-GUARD
Model: PG0404CE, PG0608CE, PG0814CE, PG1016CE, PG1225CE, SPG0404CE, SPG0406CE, SPG0608CE, SPG0814CE, SPG1016CE
Lot: All lots within expiry

MD: Extra-gynaecological surgical mesh, collagen, non-bioabsorbable

DE-1

Vk_20240304_30

Drägerwerk AG & Co. KGaA

Perseus A500
Model: MK06000
S/N: all

MD: Anesthesia Units

DE-1
FR-1
IT-1

Vk_20240311_06

DH Healthcare GmbH

DeepUnity Diagnost
SW-Version: see FSN

MD: Picture Archiving And Communication Systems

DE-1
FR-1
EN-1

Vk_20240227_23

DH Healthcare GmbH

DeepUnity Viewer
SW-Version: see FSN

MD: Picture Archiving And Communication Systems

DE-1
FR-1
EN-1

Vk_20240227_24

DH Healthcare GmbH

DeepUnity Diagnost
SW-Version: see FSN

MD: Picture Archiving And Communication Systems

DE-1
FR-1
EN-1

Vk_20240228_18

Epic Systems Corporation

Regulated Decision Support Framework
SW-Version: See FSN

MD: Clinical management support software

EN-1

Vk_20240304_15

B. Braun Surgical S. A.

NOVOSYN VIOLET
Model: C0068092N1 & C0068242N1
Lot: 3403VG & 3402U6

MD: Polyester suture, bioabsorbable, multifilament, non-antimicrobial

DE-1
FR-1

Vk_20240229_13

(Updated )

Gyrus ACMI Inc.

SOLTIVE SuperPulsed Laser System
Model: TFL-PLS, TFL-SLS; EGTFL-PLS, EGTFL-SLS
S/N: All

MD: General/multiple surgical solid-state laser system

DE-1
FR-1
EN-1

Vk_20240223_22

Covidien llc

Auto Suture Structural Balloon Trocar
Model: OMS-T10SB
Lot: all

Auto Suture Blunt Tip Trocar
Model: OMS-T10BT, OMS-T10BTNL, OMS-T10BTS, OMS-T10BTSNL, OMS-T12BT and OMS-T12BTNL
Lot: All

MD: Laparoscopic multi-instrument access port, single-use

MD: Laparoscopic multi-instrument access port, single-use

DE-1
FR-1
IT-1

Vk_20240304_29

QuidelOrtho (Ortho-Clinical Diagnostics Inc.)

VITROS Chemistry Products Performance Verifiers I and II
Model: 8067324 (I), 8231474 (II)
Lot: Q1174, R1176
S/N: Not Applicable
SW-Version: Not Applicable

IVD: Multiple-type clinical chemistry analyte profile IVD, control

DE-1
EN-1

Vk_20240305_01

Hologic, Inc.

Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay
Model: PRD-07400
Lot: All lot numbers

IVD: Multiple Viruses – Multiplex Assays – Other

DE-1
EN-1

Vk_20240304_31

(Updated )

Siemens Healthcare Diagnostics Inc.

ADVIA Centaur Cortisol assay
Model: see FSN
Lot: see FSN
S/N: N/A

Atellica IM Cortisol
Model: see FSN
Lot: see FSN
S/N: N/A

IVD: Total cortisol IVD, kit, chemiluminescent immunoassay

IVD: Total cortisol IVD, kit, chemiluminescent immunoassay

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

Vk_20230321_25

Siemens Medical Solutions USA Inc.

ACUSON Redwood ultrasound system
Model: 11503314
SW-Version: VA10A to VA10G

MD: General-purpose ultrasound imaging system

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

Vk_20240229_09

Siemens Medical Solutions USA Inc.

ACUSON Juniper Diagnostic Ultrasound System
Model: 11335791, 11653093 (System IVK: 11335791)
SW-Version: See section 8 of this report.

MD: General-purpose ultrasound imaging system

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

Vk_20240228_21

Beckman Coulter , Inc.

Access Substrate
Model: 81906
Lot: see FSN

IVD: Substrates

DE-1
FR-1
EN-1

Vk_20240228_03

Bühlmann Laboratories AG

BÜHLMANN GanglioCombi MAG ELISA
Model: EK-GCM
Lot: 3377N, 3678N, 4079.N
S/N: N.A.

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

DE-1
FR-1
EN-1

Vk_20240226_29

NEXUS / DIS GmbH

Vital Signs Monitoring Instruments
SW-Version: 2.6.0 – 2.6.1100, 2.7.0 – 2.7.104, 2.8.0 – 2.8.305, 2.9.0 – 2.9.7, 2.10.0 – 2.10.2

MD: Vital Signs Monitoring Instruments – Medical Device Software

DE-1
FR-1
IT-1

Vk_20240228_19

(Updated )

Maquet SAS

Untersuchungs- und OP-Leuchten
Model: All Maquet SAS products
Lot: N/A
S/N: See FSN
SW-Version: N/A

MD: Operating room light

DE-1
FR-1
IT-1

Vk_20240209_19

(Updated )

Angiokard Medizintechnik GmbH

Infiltrationsset
Model: 162514
Lot: 238934-000

Angiographie-Set
Model: 165422
Lot: 238937-000

MD: Stopcocks

MD: Stopcocks

DE-1

Vk_20240209_03

Siemens Medical Solutions USA Inc.

ACUSON Maple/Maple Select ultrasound system
Model: 11711750, 11711779 (System IVK: 11711750)
SW-Version: VA10A

MD: General-purpose ultrasound imaging system

DE-1
EN-1

Vk_20240229_10

(Updated )

Waldemar Link GmbH & Co. KG

Link OptiStem, Rasp Handle Stainless Steel
Model: 17-5220/01
Lot: C010108, C151519

MD: Surgical instrument handle, non-torque-limiting

DE-1
FR-1
IT-1
EN-1
EN-2-DISTR
EN-2-HCP

Vk_20230725_01

(Updated )

Reison Medical AB

Anesthesia frame Carbon
Model: 10-313; reison product catalogue-MM001 Ver.04
Lot: 32597

MD: Respiratory And Anaesthesia Devices – Other

DE-1
EN-1

Vk_20230907_07

(Updated )

E.M.S. Electro Medical Systems S.A.

NIGHT CLEANER Bottle
Model: EG-120
Lot: 16442-200, 16744-30, 16849-30

PIEZON Bottle
Model: EG-111
Lot: 16442-190, 16694-30

WATER Bottle
Model: EG-121
Lot: 16457-10, 16457-80, 16457-120, 16457-130, 16457-140, 16866-80

MD: Dental abrasive air jet system

MD: Dental abrasive air jet system

MD: Dental abrasive air jet system

DE-1-DISTR
DE-1-HCP
FR-1-DISTR
FR-1-HCP
FR-2-DISTR
FR-2-HCP
IT-1-DISTR
IT-1-HCP

Vk_20240212_11

(Updated )

Philips Medical Systems Nederland B.V.

Philips Azurion system
Model: 722223
S/N: 475, 474
SW-Version: n/a

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

DE-1
EN-1

Vk_20240206_35

(Updated )

Abbott Laboratories

ARCHITECT STAT Myoglobin Reagent Kit
Model: 2K43-25, 2K43-20
Lot: 50808UN23, 60104UN23

IVD: Myoglobin IVD, kit, chemiluminescent immunoassay

DE-1
FR-1
EN-1

Vk_20240223_18

BEAVER-VISITEC INTERNATIONAL, INC

IRRIGATION HANDLE
Model: 581012
Lot: 21C0925, 21C0926

MD: Ophthalmic Devices – Other

DE-1

Vk_20240219_01

(Updated )

Roche Diagnostics GmbH

Elecsys Troponin T hs
Model: 08469717190, 08469873190, 09315322190, 09315357190
SW-Version: n/a

Elecsys Troponin-T hs STAT
Model: 08469814190, 09315349190
SW-Version: n/a

IVD: Troponin I/t

IVD: Troponin I/t

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

Vk_20230109_15

(Updated )

Waldemar Link GmbH & Co. KG

Lubinus SPII
Model: see FSN
Lot: all

MD: Uncoated hip femur prosthesis, modular

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

Vk_20240206_03

Boston Scientific Corporation

iSLEEVE 14F
Model: H74939349140
Lot: see FSN

MD: Vascular catheter introduction set, nonimplantable

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

Vk_20240220_29

(Updated )

Datascope Corp.

CARDIOSAVE Hybrid Intra-Aortic Balloon Pump
Model: 0998-XX-0800-XX
Lot: All
S/N: All Cardiosave serial numbers distributed since March 6, 2012

MD: Intra-aortic balloon pump

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

Vk_20240214_24

(Updated )

Philips Medical Systems Nederland B.V.

MultiDiagnost Eleva

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

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

Vk_20230828_10

(Updated )

Changzhou Hekang Medical Instruments Co., Ltd.

Gallensekretbeutel
Model: 74.5286.005
Lot: 230309

MD: Gallensekretbeutel 1, 5 l

DE-1
FR-1
IT-1

Vk_20240214_29

Datascope Corp.

Cardiosave Intra-Aortic Balloon Pump
Model: 0998-XX-0800-XX
Lot: All
S/N: All Cardiosave serial numbers distributed since March 6, 2012 to July 24, 2017.

MD: Intra-aortic balloon pump

DE-1
FR-1
IT-1

Vk_20240214_21

Bonebridge AG

SALGINA 2.5MM Volar Distal Radius Sytem
Model: B-112000, B-111000, B-112100, B-111100, B-112010, B-111010, B-112110, B-111110
Lot: all

MD: Bone Fixation Plates

DE-1

Vk_20240215_15

Agfa NV

AGFA Digital Radiography X-Ray system DX-D 100
Model: 5411/050, A5411/0300, A5411/0400

MD: Computed radiography digital imaging scanner

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

Vk_20240207_06

Caesarea Medical Electronics Limited

BD BodyGuard MicroSets
Model: 100-184XSYK, 120-160XCSEK, 120-160XCSK
Lot: See FSN

MD: Electric infusion pump administration set, single-use

FR-1
IT-1

Vk_20240221_12

Cook Incorporated

Dilators – Coons Taper
Model: JCD22.0-38-20-COONS
Lot: 15767086
SW-Version: N/A

Entuit Secure Gastrointestinal Suture Anchor Set
Model: GIAS-SRM-ADJ-2
Lot: 15791906

Chiba Biopsy Needles
Model: DCHN-22-15.0; DCHN-22-15.0-U
Lot: 15785990; 15784638, 15784722

MD: Fascial tissue dilator, single-use

MD: Gastrostomy T fastener

MD: Body aspiration needle, single-use

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

Vk_20240226_05

DH Healthcare GmbH

ORBIS Medication 3.x
SW-Version: 03.19.00.00

MD: General Medicine Instruments – Other

DE-1
EN-1

Vk_20240223_21

DH Healthcare GmbH

ORBIS Medication 3.x
SW-Version: 03.15.02.00

MD: General Medicine Instruments – Other

DE-1
EN-1

Vk_20240220_04

(Updated )

Mölnlycke Health Care AB

Endoretrival Pouches, Procedure Packs with Endoretrival Pouches – See FSN
Model: See FSN
Lot: See FSN

MD: Tissue extraction bag

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

Vk_20240216_02

(Updated )

ACUTRONIC Medical Systems AG

Fabian HFO
SW-Version: SW 5.2.2

fabian Therapy evolution
SW-Version: SW 5.2.2

fabian +nCPAP evolution
SW-Version: SW 5.2.2

MD: Neonatal intensive-care ventilator

MD: Neonatal intensive-care ventilator

MD: Neonatal intensive-care ventilator

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

Vk_20240201_17

(Updated )

Thoratec Corporation

Heartmate III
Model: 106524, 106524INT, 106015, 106016, 102139, 103695, 104912, 103693
S/N: All serial numbers

HeartMate II LVAS
Model: 106524, 106524INT, 106015, 106016, 102139, 103695, 104912, 103693
S/N: All serial numbers

AIMD: Implantable ventricular circulatory assist system

AIMD: Implantable ventricular circulatory assist system

DE-1
FR-1
EN-1

Vk_20240220_01

(Updated )

Datascope Corp.

Cardiosave Intra-Aortic Balloon Pump
Model: 0998-XX-0800-XX
Lot: All
S/N: All Cardiosave serial numbers distributed since March 6, 2012 to July 24, 2017

MD: Intra-aortic balloon pump

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

Vk_20240214_25

(Updated )

Datascope Corp.

Cardiosave Intra-Aortic Balloon Pump
Model: 0998-XX-0800-XX
Lot: All
S/N: All Cardiosave serial numbers distributed since March 6, 2012 to July 24, 2017

MD: Intra-aortic balloon pump

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

Vk_20240214_26

Applied Medical Resources Corporation

Epix Universal Clip Applier
Model: CA500, Kits see list attached in FSN
Lot: See list attached

MD: Ligation clip, metallic

EN-1

Vk_20240208_26

Fresenius Kabi AG

STAY SAFE CATHETER EXTENSION LUER-LOCK
Model: 2843181, F00005375, 2843241, 2843251, 2843191
Lot: All

MD: Continuous ambulatory peritoneal dialysis (CAPD) transfer set

DE-1
FR-1
IT-1

Vk_20240216_32

Thommen Medical AG

VARIOflex abutment set for bridge, PF 4.5
Model: 1.04.837
Lot: 33054

MD: Dental Implants

FR-1

Vk_20240216_31

(Updated )

Unimax Medical Systems Inc.

Detachable EndoRetrieval Pouch
Model: 899102, 899103, 899104, 899112
Lot: See FSN

MD: Minimally Invasive Surgery Recovery Bags

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

Vk_20240206_17

(Updated )

Medos International SARL

Cerebase Guide Sheath
Model: GS9070SD, GS9080SD, GS9090SD, GS9095SD
Lot: See FSN

MD: Vascular guide-catheter, single-use

DE-1
FR-1
EN-1

Vk_20240205_05

Mediberg S.r.l. Unipersonale

Custom Pack Chirurgia Universale / Ostetricia
Model: 800462AAGSCHC, 804115AAGSCHC
Lot: 235990, 236218

MD: Surgical Procedural Kits (excluding Surgical Instrument Kits)

EN-1

Vk_20240215_03

(Updated )

Medtronic Xomed Inc

EMG TUBE REINFORCED 6MM / PRO PIN; EMG TUBE REINFORCED 7MM / PRO PIN (1/EA); EMG TUBE REINFORCED 8MM / PRO PIN (1/EA)
Model: 8229306, 8229307, 8229308
Lot: all

ENDOTRACHEAL TUBE 6MM EMG CONTACT (1/EA); ENDOTRACHEAL TUBE 7MM EMG CONTACT (1/EA); ENDOTRACHEAL TUBE 8MM EMG CONTACT (1/EA)
Model: 8229506, 8229507, 8229508

MD: Reinforced endotracheal tube, single-use

MD: Basic endotracheal tube, single-use

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

Vk_20220506_10

(Updated )

Voco GmbH

Ionolux
Model: see FSN
Lot: see FSN

MD: Glass ionomer dental cement

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

Vk_20240202_33

(Updated )

Voco GmbH

Ionostar Plus
Model: see FSN
Lot: see FSN

MD: Glass ionomer dental cement

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

Vk_20240202_34

(Updated )

Tandem Diabetes Care, Inc.

t:slim X2 Insulin Pump with Control-IQ Technology
Model: 1005611
SW-Version: 7.4.3 or lower

t:slim X2 with Basal-IQ Technology
Model: 1006419
SW-Version: 6.4.1 or lower

MD: Ambulatory insulin infusion pump, electronic

MD: Ambulatory insulin infusion pump, electronic

DE-2-HCP
DE-2-User
DE-3-HCP
FR-2-HCP
FR-2-User
FR-3-HCP
IT-2-HCP
IT-2-User
IT-3-HCP
EN-2-HCP
EN-2-User
EN-3-HCP

Vk_20230223_21

(Updated )

Medtronic Inc.

Duet External Drainage and Monitoring System
Model: see FSN
Lot: see FSN

Duet External Drainage and Monitoring System, SmartSite Iniection Sites, Ventricular Catheter
Model: see FSN
Lot: see FSN

Duet External Drainage and Monitoring System, Interlink Iniection Sites, Ventricular Catheter
Model: see FSN
Lot: see FSN

Duet External Drainage and Monitoring System, Interlink Iniection Sites, Lumbar Catheter
Model: see FSN
Lot: see FSN

MD: Cerebrospinal fluid external drainage kit

MD: Ventricular cerebrospinal fluid drainage catheterization kit

MD: Ventricular cerebrospinal fluid drainage catheterization kit

MD: Lumbar cerebrospinal fluid drainage catheterization kit

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

Vk_20240126_28

BioFire Diagnostics, LLC

BioFire BCID2 Panel
Model: RFIT-ASY-0147; RFIT-ASY-0147
Lot: All BIOFIRE BCID2 Panel lot manufactured in the past 12 months, if used with BD BACTEC blood culture media
S/N: N/A

IVD: Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry

DE-1
FR-1
EN-1

Vk_20240206_11

(Updated )

BioFire Diagnostics, LLC

FilmArray Gastrointestinal (GI) Panel
Model: RFIT-ASY-0116; RFIT-ASY-0104; RFIT-ASY-0116; RFIT-ASY-0104
Lot: All lot numbers, All unexpired product

IVD: Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

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

Vk_20240206_14

DH Healthcare GmbH

ORBIS Medication 3.x
SW-Version: 03.18.02.00

MD: General Medicine Instruments – Other

DE-1
EN-1

Vk_20240207_20

Ivoclar Vivadent AG

Bluephase Style
Model: 637937
S/N: 1104003167

MD: Dental/surgical polymerization lamp

DE-1

Vk_20240212_35

(Updated )

Medtronic Inc.

LINQ II Insertable Cardiac Monitor
Model: LNQ22
Lot: all

AIMD: Implantable cardiac monitor

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

Vk_20210602_17

Siemens Healthcare Diagnostics Inc.

Atellica UAS 800 Analyzer
S/N: All
SW-Version: All versions up to and including v4.0.400

Atellica 1500 Automated Urinalysis System
S/N: All
SW-Version: All versions up to and including v4.0.400

IVD: Urine analyser IVD, laboratory

IVD: Urine analyser IVD, laboratory

DE-1
FR-1
EN-1

Vk_20240131_08

(Updated )

Philips Medical Systems Nederland B.V.

Allura Centron
Model: see FSN
S/N: see FSN

Philips Azurion system
Model: See FSN
S/N: see FSN

MultiDiagnost Eleva
Model: see FSN
S/N: see FSN

Philips Allura Xper
Model: see FSN
S/N: See FSN
SW-Version: Not Applicable

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

Vk_20230809_21

IMM – International Medical Mediation

PHLEBOSET bloodletting set
Lot: See FSN

MD: Blood Bags And Kits – Other

FR-1
EN-1

Vk_20240202_09

(Updated )

Medtronic Navigation Inc.

StealthStation S8 Software App
Model: 9735762
S/N: All
SW-Version: 2.0, 2.0.1

MD: Multi-purpose stereotactic surgery system

DE-1
DE-2.1
DE-2.2
FR-1
FR-2.1
FR-2.2
IT-1
IT-2.1
EN-1
EN-2.1
EN-2.2

Vk_20230928_19

B. Braun Melsungen AG

Original Perfusor Line
Model: SEE FSN
Lot: SEE FSN

MD: Intravenous administration tubing extension set

DE-1
FR-1
IT-1

Vk_20240205_31

(Updated )

BioFire Diagnostics, LLC

BioFire FilmArray Pneumonia plus (PN plus) Panel
Model: RFIT-ASY-0143 (30 Tests)
Lot: All unexpired lots

IVD: Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

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

Vk_20240130_37

Gyrus ACMI, Inc.

Soltive SuperPulsed Laser Fiber
Model: TFL-PLS, TFL-SLS; EGTFL-PLS, EGTFL-SLS
S/N: All

MD: General/multiple surgical solid-state laser system

DE-1
FR-1

Vk_20240201_26

(Updated )

Ossenberg GmbH

KLASSIKER
Model: 220 & 230

MD: Walkers

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

Vk_20231206_11

Siemens Healthcare Diagnostics Inc.

Atellica IM Erythropoietin (EPO)
Model: 10733006
Lot: 53982039, 55439041
S/N: N/A

ADVIA Centaur Erythropoietin (EPO)
Model: 10995096
Lot: 53984040, 55443042

IVD: Erythropoietin (EPO) IVD, kit, chemiluminescent immunoassay

IVD: Erythropoietin (EPO) IVD, kit, chemiluminescent immunoassay

DE-1
EN-1

Vk_20240130_16

Thommen Medical AG

Impression coping
Model: 3.03.079
Lot: 30972

MD: Dental Implants – Accessories

DE-1
FR-1

Vk_20240205_24

(Updated )

Philips Medical Systems Nederland B.V.

Allura Xper

Allura Centron

Azurion

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

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

MD: Stationary angiographic x-ray system, digital

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

Vk_20240108_15

Fujifilm Corporation

FDR Nano
Model: DR-XD 1000
S/N: All devices

MD: Mobile basic diagnostic x-ray system, digital

DE-1
FR-1
IT-1

Vk_20240131_11

AngioDynamics, Inc.

AngioDynamics MiniStick Max Coaxial MicroIntroduce
Model: H965457491, H965457501, H965457541, H965457561, H965457591, H965457621
Lot: 5784036, 5784134, 5789978, 5790448, 5791590, 5791591, 5791594, 5794604, 5794606, 5796662, 5797465, 5797468, 5799613, 5803526, 5804390, 5805056

MD: Vascular catheter introduction set, nonimplantable

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

Vk_20240206_01

Datex-Ohmeda Inc.

Care Plus Incubator
Model: 1000, 2000, 3000, 4000

Lullaby Incubator
Model: XP, TR

MD: Conventional infant incubator

MD: Conventional infant incubator

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

Vk_20240202_36

(Updated )

Abbott Ireland Diagnostic Division

Alinity i Anti-HBs Reagent Kit
Model: 07P8952, (07P8975 China only)
Lot: 51441FN00, (51441FN01 China only)

IVD: Hepatitis B virus surface total antibody IVD, kit, chemiluminescent immunoassay

IT-1
EN-1

Vk_20240126_25

Smiths Medical ASD, Inc.

CADD Extension Set
Model: see FSN
Lot: see FSN

CADD Administration Set
Model: see FSN
Lot: see FSN

MD: Intravenous administration tubing extension set

MD: Electric infusion pump administration set, single-use

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

Vk_20240205_18

(Updated )

DH Healthcare GmbH

ORBIS Medication 3.x
SW-Version: 03.16.00.00

MD: General Medicine Instruments – Other

DE-1
EN-1

Vk_20240130_01

NeuMoDx Molecular Inc.

NeuMoDx HIV-1 Quant Test Strips
Model: 300500
Lot: 101817, 101974, 101976, 106373, 108404, 115463, 116838, , 116839, 116840, 119840, 120278, 120279, 120280, 122175, , 122176, 125555, 125926, 126901, 126902, 127665, 127671, , 127672, 127673, 127674, 128015, 128198, 128200

IVD: HIV-1 Quant Test

DE-1
FR-1
IT-1

Vk_20240202_32

(Updated )

DH Healthcare GmbH

ORBIS Medication 3.x
SW-Version: 03.18.03.01

MD: General Medicine Instruments – Other

DE-1
EN-1

Vk_20240129_21

(Updated )

QuidelOrtho (Ortho-Clinical Diagnostics Inc.)

VITROS 3600
Model: 6802783, 6802914
S/N: See FSN

VITROS 5600
Model: 6802413, 6802915
S/N: See FSN

VITROS XT7600
Model: 6844461
S/N: See FSN
SW-Version: Not Applicable

IVD: Chemiluminescent immunoassay analyser IVD

IVD: Chemiluminescent immunoassay analyser IVD

IVD: Multiple clinical chemistry analyser IVD, laboratory

DE-1
EN-1

Vk_20240125_20

(Updated )

William A. Cook Australia Pty. Ltd.

MINC+ Benchtop Incubator
Model: K-MINC-2000; G44429

MD: Assisted reproduction heater/incubator

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

Vk_20231206_02

GE Healthcare Austria GmbH & Co OG

IC9-RS
S/N: See FSN

MD: Rectal/vaginal ultrasound imaging transducer

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

Vk_20240129_04

OSATU Sociedad Cooperativa

Bexen Cardio
Model: Reanibex 100
S/N: see FSN
SW-Version: versions 2.06 and lower

MD: Non-rechargeable public semi-automated external defibrillator

DE-1
FR-1
IT-1

Vk_20240119_29

(Updated )

Becton Dickinson Diagnostic Systems

BD MAX Enteric Viral Panel-NR
Model: 443987
Lot: 3081625

IVD: Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

DE-1
EN-1

Vk_20240122_30

(Updated )

Ecolab Deutschland GmbH

Incidin OxyWipe S
Model: 3082240; 3116020; 3092040; 3116100;
Lot: all Lots
S/N: all S/N

Incidin OxyFoam S
Model: 3115790; 3115900; 3082060; 3087450
Lot: all Lots
S/N: all S/N

MD: Medical device cleaning/disinfection wipe

MD: Medical device disinfection agent

DE-1
FR-2
IT-1

Vk_20231127_06

ImpediMed Limited

SOZO Bilateral Arm L-Dex Software
SW-Version: 1.4, 4.1, 5.0

MD: Bioelectrical body composition analyser

DE-1
FR-1
EN-1

Vk_20230824_24

(Updated )

icotec ag

icotec Torque Wrench
Model: REF 42-702
Lot: n.a.
S/N: all Serial Numbers

MD: Neurosurgery And Spinal Surgery Instrument Kits, Reusable

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

Vk_20231219_01

(Updated )

Covidien llc

Sofsilk Wax/silicone Coated Braided Silk
Model: affected devices in Switzerland: S-303 SOFSILK* 4-0 BLK 12x75CM PCT X36; SS-681 SOFSILK 6-0 BLK 45CM C12 X36
Lot: affected devices in Switzerland: S303: D2D2120RY; SS-681: D2G0795FRY

MD: Silk suture

DE-1
DE-2
EN-2

Vk_20231221_06

(Updated )

Thermo Fisher Scientific Oy

Urea
Model: 981954
Lot: W341, W407, W514, W546, W739, W831, W955, W921

IVD: Urea/Blood Urea Nitrogen

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

Vk_20240104_24

Waldemar Link GmbH & Co. KG

BiMobile Dual Mobility System, Liner
Model: 184-280/12, 184-260/12
Lot: LOT 2339039 , LOT 2334253 , LOT 2325426, LOT 2219070
SW-Version: N/A

MD: Constrained polyethylene acetabular liner

DE-1
EN-1

Vk_20240122_19

(Updated )

Philips Medical Systems Nederland B.V.

Spectral CT 7500
Model: 728333, 728340
SW-Version: 5.0.0.X

MD: Full-body CT system

DE-1
FR-1
EN-1

Vk_20231204_27

(Updated )

Philips Medical Systems Nederland B.V.

BrightView
Model: 882480

BrightView X
Model: 882478

BrightView XCT
Model: 882482

MD: Stationary gamma camera system

MD: Stationary gamma camera system

MD: PET/CT system

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

Vk_20231204_25

H.S. Hospital Service S.p.A.

AMICA GEN
Model: AGN-H-1.x, AGN-3.x, AGN-R-1.x
S/N: Alll

MD: Microwave hyperthermia system

EN-1

Vk_20240116_01

MAQUET Cardiopulmonary GmbH

Bubble Sensor BS 3/8×3/32 L1.7
Model: 701055720
Lot: N/A
S/N: 90041745 to 90042097

MD: Cardiopulmonary bypass system, roller type

DE-1
EN-1

Vk_20240122_28

GE Healthcare

Centricity Anesthesia

Centricity Critical Care

Centricity High Acuity Critical Care

Centricity High Acuity Anesthesia

MD: Anaesthesia information system application software

MD: Patient health record information system

MD: Patient health record information system

MD: Patient health record information system

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

Vk_20240122_06

(Updated )

Maquet Critical Care AB

Servo-n
Model: Base unit Servo-n, Servo-n HFOV SW option; 6688600, 6888011
S/N: see FSN
SW-Version: 4.4, 4.5

MD: Neonatal intensive-care ventilator

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

Vk_20240115_24

3M (Schweiz AG)

3M Surgical / 3M Specialty Clipper Blades
Model: 9660 and 9690
Lot: all lots

MD: Surgical hair clippers blade

DE-1
FR-1
IT-1

Vk_20240116_08

DH Healthcare GmbH

ORBIS Medication 3.x

MD: General Medicine Instruments – Other

DE-1
EN-1

Vk_20240116_09

DH Healthcare GmbH

ORBIS Medication 3.x

MD: General Medicine Instruments – Other

DE-1
EN-1

Vk_20240112_23

D.O.R.C. Dutch Ophthalmic Research Center

DORC Directional Laser Probe
Model: 7220.ALC; 7220.DORC; 7220.IRI; 7223.ALC; 7223.DORC; 7223.IRI; 7225.ALC; 7225.DORC; 7225.IRI; 7227.ALC; 7227.DORC; 7227.IRI
Lot: Affected lots range starts with a number between 2470 and 18705. E.g. LOT 4330-*-*-1
SW-Version: N.A.

MD: Ophthalmic laser system beam guide

DE-1
FR-1
IT-1

Vk_20240115_19

(Updated )

Olympus Medical Systems Corp.

Thunderbeat Type – S
Model: TB-0535FCS for Thunderbeat Type S, 35 cm and TB-0545FCS for Thunderbeat Type S, 45 cm; EGTB-0535FCS for Thunderbeat Type S, 35 cm / TB-0535FCS and EGTB-0545FCS for Thunderbeat Type S, 45 cm / TB-0545FCS
Lot: see FSN

MD: Soft-tissue ultrasonic surgical system holder/tip, single-use

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

Vk_20230922_01

Turkuaz Saglik

KONIX Sterile Lido C Lubricant Gel
Model: see FSN
Lot: see FSN
SW-Version: NA

MD: Urethral Prostatic And Bladder Catheters – Other

DE-1
FR-1

Vk_20231220_18

Mint Medical GmbH

Mint Lesion
Model: 3.8.6, 3.9, 3.9.1, 3.9.2

MD: Radiology Instruments – Software Accessories

DE-1
FR-1
EN-1

Vk_20240111_07

(Updated )

Philips Respironics, Inc

Trilogy Evo
Model: See FSN
Lot: Not Applicable
SW-Version: Not Applicable

Trilogy Evo O2
Model: See FSN
Lot: Not Applicable

MD: Portable electric ventilator

MD: Portable electric ventilator

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

Vk_20231130_13

TORNIER – WRIGHT FRANCE

Pyrocardan
Model: PYRC-14; PYRC-15
Lot: PYRC-14 : Starting with 4638AZ, PYRC-15: Starting with 4780AZ, See full list in Attachment A of the FSN

MD: Carpometacarpal interpositional spacer, non-bioabsorbable

DE-1
FR-1
IT-1

Vk_20240105_06

Gyrus ACMI, Inc.

SG PK CUTTING FORCEPS
Model: TPK-CF0533; PK-CF0533
Lot: see FSN

MD: Endoscopic electrosurgical handpiece/electrode, bipolar, single-use

DE-1
FR-1

Vk_20240110_14

Schiller Medical

DEFIGARD TOUCH7
Model: DEFIGARD Touch7
S/N: All
SW-Version: Soft 8 and lower

MD: Physiologic-monitoring defibrillation system

DE-1
FR-1
IT-1

Vk_20231110_27

Zimmer Surgical, Inc.

Dermacarriers
Model: 00-2195-013-00
Lot: 65292843; 65390419

MD: Skin graft carrier

DE-1
FR-1
EN-1

Vk_20240111_23

Thoratec Corporation

HeartMate Touch Communication System
Model: HMT1150
S/N: Serial numbers with software version 1.0.32
SW-Version: 1.0.32

AIMD: Multiple active implantable device programmer

FR-1
EN-1

Vk_20240110_03

Philips Medical Systems Nederland B.V.

Philips Intera, Achieva, Ingenia CX
Model: See FSN
S/N: See FSN

MD: Full-body MRI system, superconducting magnet

DE-1
FR-1
EN-1

Vk_20240109_10

(Updated )

Covidien llc

INVOS Reusable Sensor Cable for PM7100
Model: PMAC71RSC
Lot: 2023-02-22, 2023-04-28, 2023-05-04, 2023-07-20

INVOS Reusable Infant Sensor Adapter Cable for PM7100
Model: PMAC71RIC
Lot: 20221220, 20230721

MD: Electrical-only medical device connection cable, reusable

MD: Electrical-only medical device connection cable, reusable

FR-1
EN-1

Vk_20240111_01

(Updated )

CompuGroup Medical Software GmbH

CGM CLINICAL Medication

MD: Medical Device Software – Not Included In Other Classes

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

Vk_20240104_21

(Updated )

Drägerwerk AG & Co. KGaA

Atlan
Model: 8621300, 8621400, 8621500, 8621600
S/N: all

MD: Anesthesia Units

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

Vk_20231204_01

(Updated )

Gyrus ACMI, Inc.

TFL Fiber Cleaver, TFL Fiber Stripper/ Olympus
Model: TFL-AFC, TFL-AFS150, TFL-AFS200, TFL-AFS365, TFL-AFS550, TFL-AFS940
Lot: All lots

MD: General/multiple surgical solid-state laser system

DE-1
EN-1

Vk_20231229_24

(Updated )

Remote Diagnostic Technologies Ltd.

Tempus Pro Patient Monitor
Model: 00-1004, 00-1004-R, 00-1007, 00-1007-R, 00-1024-R, 00-1026-R

MD: Multiple vital physiological parameter monitoring system, clinical

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

Vk_20230828_17

(Updated )

Löwenstein Medical Technology GmbH + Co. KG

LM150TD
Model: LUISA, TIVAN LS, Life One
S/N: all

MD: Portable electric ventilator

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

Vk_20231220_28

Balt USA

Optima Coil System
Model: OPTI0507CSFMX, OPTI0515HSFMX, OPTI0517CSFMX, OPTI0615HSFMX, OPTI1040HSFMX, OPTI2050CSFMX
Lot: F210200528, F230200068, F210300431, F230200078, F210300435, F201000513

Prestige Coil System

MD: Detachable Coil Equipment For Brain Aneurysms

MD: Detachable Coil Equipment For Brain Aneurysms

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

Vk_20240108_02

Löwenstein Medical Innovation GmbH & Co. KG

elisa 300
Model: elisa 300 ag-480300, elisa 300 ag-480310
S/N: 03233150
SW-Version: <2.10.7 und <2.13.3 (s. FSN)

elisa 500
Model: elisa 500 ag-480500, elisa 500 ag-480510
S/N: 05200730
SW-Version: <2.10.7 und <2.13.3 (s. FSN)

elisa 600
Model: elisa 600 0400600, elisa 600 ag-370600, elisa 600 ag-370605
S/N: 0400600hul06184472
SW-Version: <2.10.7 und <2.13.3 (s. FSN)

elisa 800
Model: elisa 800 ag-370830, elisa 800 ag-370835, elisa 800 0400810
S/N: 0400810hul08184077, 0400810hul08184078, 0400810hul08184082, 0400810hul08184083, 0400810hul08184084, 0400810hul08184085, 0400810hul08174055
SW-Version: <2.10.7 und <2.13.3 (s. FSN)

elisa 800 vit
Model: elisa 800 VIT 0400800, elisa 800 VIT ag-370830-vit, elisa 800 VIT ag-370835-vit, elisa 800 VIT ag-370836-vit
S/N: 0400800hul08179006, 0400800hul08189033, 0400800hul08179017, 0400800hul08150086
SW-Version: <2.10.7 und <2.13.3 (s. FSN)

MD: Intensive care ventilator

MD: Intensive care ventilator

MD: Intensive care ventilator

MD: Intensive care ventilator

MD: Intensive care ventilator

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

Vk_20240104_14

(Updated )

Corcym S.r.l.

Perceval Plus Sutureless Aortic Heart Valve
Model: PVF-S, PVF-M, PVF-L, PVF-XL
S/N: PE9907A, PE9911A, PF2412A

MD: Aortic heart valve bioprosthesis

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

Vk_20231229_04

(Updated )

Meyra GmbH

iCHAIR SKY
Model: 1.620; 9162000001392/ 9162000002384
S/N: 6296782/ 6313410

MD: Electric Wheelchairs

DE-1
FR-1
IT-1

Vk_20231227_30

Philips Medical Systems Nederland B.V.

Philips Azurion system
Model: 722063, 722221, 722064, 722222, 722227, 722228, 722067, 722225, 722068, 722226, 722078, 722223, 722079, 722224, and 722280
SW-Version: R1.0, R1.1, R1.2, R2.0, R2.1, and R2.2

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

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

Vk_20231212_17

Laboratoire Dencott

ERG Dencott
Model: all
Lot: all

MD: Electroretinograph electrode

FR-1

Vk_20240105_18

Beckman Coulter , Inc.

Access Ultrasensitive Insulin Assay
Model: 33410

DxI 9000 Access Immunoassay Analyzer
Model: C11137
SW-Version: 1.16 or prior

IVD: Insulin

IVD: Chemiluminescent immunoassay analyser IVD

DE-1
EN-1

Vk_20240104_09

Shenzhen Mindray Scientific Co., Ltd.

Benefusion nSP

MD: Bedside syringe pump

DE-1
FR-1
IT-1

Vk_20240105_15

Becton Dickinson Diagnostic Systems

BD Sensi-Disc
Model: see FSN
Lot: see web-tool of manufacturer

IVD: Antibacterial susceptibility testing disc IVD

DE-1
FR-1
IT-1

Vk_20240103_04

(Updated )

Cristalens Industrie

Clare

Quatuorevo

Cristal

Artis

Lucis

MD: Posterior-chamber intraocular lens, pseudophakic

MD: Posterior-chamber intraocular lens, pseudophakic

MD: Posterior-chamber intraocular lens, pseudophakic

MD: Lens

MD: Lens

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

Vk_20231222_36

Datex-Ohmeda Inc.

EVair

MD: Medical device air compressor

DE-1
FR-1
IT-1

Vk_20240103_02

Agilent Technologies Singapore Pte Ltd.

Alissa Interpret
Model: K5849AA
SW-Version: v5.3.7 and v5.4.3

IVD: Nucleic Acid Testing Instruments

EN-1

Vk_20231222_30

(Updated )

Cordis Cashel

OPTEASE Retrieval Catheter
Model: 466C210F
Lot: All unexpired lots

OptEase Retrievable Vena Cava Filter
Model: 466F210AF, 466F210AJ, 466F210BJ
Lot: All unexpired lots

MD: Intravascular extraction catheter-snare

MD: Vena cava filter, temporary/permanent

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

Vk_20231222_25

Invacare Rea AB

Invacare Dolomite Gloss
Model: Gloss 450 / Glos 520 / Gloss 600 / Gloss 680
S/N: see FSN

MD: Handgrip disability-assistive walker, non-powered, foldable

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

Vk_20240103_25