Oktober

Datum Klasifikacijski znak JAZMP Proizvajalec Medicinski pripomoček
01.10.2019 301-248/2019 Roche Diagnostics GmbH, Germany Initiates file downloadCardiac Pipettes
02.10.2019 301-249/2019 Randox Laboratories Ltd, Great Britain Initiates file downloadLiquid Cardiac Controls
02.10.2019 301-250/2019 Mathys AG Bettlach, Switzerland Initiates file downloadMeasuring impactor
03.10.2019 301-251/2019 Medtronic Inc., USA Affected Devices:
Initiates file downloadClaria MRITM/Amplia MRITM/Compia MRITM/VivaTM/BravaTM CRT-Ds
Visia AFTM/ Visia AF MRI™ /EveraTM/ Evera MRI™/Primo MRITMI/Mirro MRITM ICDs
AzureTM/AstraTM IPGs
PerceptaTM/SerenaTM/SolaraTM CRT-Ps
MicraTM TPS

Affected Programmers & Remote Monitoring Software Apps:
Initiates file download2090 CareLinkTM Programmer
29901 EncoreTM Programmer
CareLink Network Application Software 2491
CareLink SmartSync™ Device Manager
MyCareLink Heart™ Mobile Application
03.10.2019 301-252/2019 Teleflex Medical, Ireland Initiates file downloadArrow® EZ-IO® Intraosseous Vascular Access Needle Sets
08.10.2019 301-253/2019 Beckman Coulter Ireland Inc. Initiates file downloadiChemVELOCITY Urine Chemistry Strips (International)
09.10.2019 301-254/2019 Ventana Medical Systems Inc, USA Initiates file downloadVENTANA HE 600 System
10.10.2019 301-256/2019 Medtronic Inc., USA Initiates file downloadSynchroMed® II Implantable Infusion Pump
11.10.2019 301-260/2019 Siemens Healthcare GmbH Initiates file downloadSOMATOM CT scanner, several types
15.10.2019 301-255/2019 Cook Incorporated, USA Initiates file downloadGuardia™ Access, Guardia™ Access Nano
15.10.2019 301-257/2019 Teleflex Medical, USA Initiates file downloadWECK® Auto Endo5® Automatic
Splikator sponk Hem-o-lok®
15.10.2019 301-258/2019 Lima Corporate SPA, Italy Initiates file downloadFRIENDLY, H-MAX C, LOGICA MIRROR, SL
16.10.2019 301-259/2019 Gambro Lundia AB, Sweeden Initiates file downloadPrismaflex System, Prismaflex 4.11, Prismaflex 5.00 Row, Prismaflex 6.10 Row, Prismaflex 7.xx Row
21.10.2019 301-261/2019 KARL STORZ SE & Co. KG, Germany Initiates file downloadC-MAC® Videolaryngoscope
21.10.2019 301-262/2019 Roche Diabetes Care GmbH, Germany Accu-Chek® Guide blood glucose meter
Initiates file downloadObvestilo 1, Initiates file downloadObvestilo 2, Initiates file downloadObvestilo 3
24.10.2019 301-263/2019 Stryker GmbH, Švica Initiates file downloadSliding Core UHMPWE
24.10.2019 301-264/2019 EUROGINE, S.L., Spain Initiates file downloadIntrauterine Device IUD Eurogine
25.10.2019 301-265/2019 Integra LifeSciences (Ireland) Ltd CUSA Clarity Console
Initiates file downloadObvestilo 1, Initiates file downloadObvestilo 2
25.10.2019 301-266/2019 Allergan, USA Initiates file downloadXEN Glaucoma Treatment System
25.10.2019 301-267/2019 Maquet Cardiopulmonary GmbH, Germany Initiates file downloadQUADROX-iD Pediatric with BIOLINE Coating
29.10.2019 301-268/2019 Philips Medical Systems, USA Initiates file downloadHeartStart XL+ Defibrillator/Monitor
29.10.2019 301-269/2019 Bard Peripheral Vascular Inc, USA Initiates file downloadBard® MaxCore® Disposable Core Biopsy Instrument
29.10.2019 301-270/2019 bioMérieux SA, France Initiates file downloadCetrimide Agar
30.10.2019 301-234/2019 Abbott, DE Initiates file download03R65-01: Alinity i Processing Module
03R67-01: Alinity c Processing Module
Posodobljeno varnostno obvestilo
30.10.2019 301-271/2019 arcomed ag, Switzerland Initiates file downloadSyramed μSP6000
Volumed μVP7000
30.10.2019 301-272/2019 Roche Diagnostics GmbH, Germany Initiates file downloadElecsys Troponin T hs, Elecsys Troponin T hs STAT
30.10.2019 301-273/2019 Philips Medical Systems, USA Initiates file downloadHeartStart XL+ Defibrillator/Monitor
31.10.2019 301-274/2019 Covidien llc, ZDA Initiates file download303000 Genius 2 Tympanic Thermometer (discontinued)
303013 Genius 3 Tympanic Thermometer
31.10.2019 301-217/2019 Roche Diabetes Care GmbH, DE Accu-Chek® Insight
Initiates file downloadObvestilo 1, Initiates file downloadObvestilo 2, Initiates file downloadObvestilo 3
31.10.2019 301-275/2019 Medtronic Navigation, Inc., ZDA  Initiates file downloadPassive Biopsy Needle Kit