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DatumKlasifikacijski znak JAZMPProizvajalecMedicinski pripomo─Źek
01.10.2019301-248/2019Roche Diagnostics GmbH, GermanyCardiac Pipettes
02.10.2019301-249/2019Randox Laboratories Ltd, Great BritainLiquid Cardiac Controls
02.10.2019301-250/2019Mathys AG Bettlach, SwitzerlandMeasuring impactor
03.10.2019301-251/2019Medtronic Inc., USAAffected Devices:
Claria MRITM/Amplia MRITM/Compia MRITM/VivaTM/BravaTM CRT-Ds
Visia AFTM/ Visia AF MRIÔäó /EveraTM/ Evera MRIÔäó/Primo MRITMI/Mirro MRITM ICDs
AzureTM/AstraTM IPGs
PerceptaTM/SerenaTM/SolaraTM CRT-Ps
MicraTM TPS

Affected Programmers & Remote Monitoring Software Apps:
2090 CareLinkTM Programmer
29901 EncoreTM Programmer
CareLink Network Application Software 2491
CareLink SmartSyncÔäó Device Manager
MyCareLink HeartÔäó Mobile Application
03.10.2019301-252/2019Teleflex Medical, IrelandArrow® EZ-IO® Intraosseous Vascular Access Needle Sets
08.10.2019301-253/2019Beckman Coulter Ireland Inc.iChemVELOCITY Urine Chemistry Strips (International)
09.10.2019301-254/2019Ventana Medical Systems Inc, USAVENTANA HE 600 System
10.10.2019301-256/2019Medtronic Inc., USASynchroMed® II Implantable Infusion Pump
11.10.2019301-260/2019Siemens Healthcare GmbHSOMATOM CT scanner, several types
15.10.2019301-255/2019Cook Incorporated, USAGuardiaÔäó Access, GuardiaÔäó Access Nano
15.10.2019301-257/2019Teleflex Medical, USAWECK® Auto Endo5® Automatic
Splikator sponk Hem-o-lok®
15.10.2019301-258/2019Lima Corporate SPA, ItalyFRIENDLY, H-MAX C, LOGICA MIRROR, SL
16.10.2019301-259/2019Gambro Lundia AB, SweedenPrismaflex System, Prismaflex 4.11, Prismaflex 5.00 Row, Prismaflex 6.10 Row, Prismaflex 7.xx Row
21.10.2019301-261/2019KARL STORZ SE & Co. KG, GermanyC-MAC® Videolaryngoscope
21.10.2019301-262/2019Roche Diabetes Care GmbH, GermanyAccu-Chek® Guide blood glucose meter
Obvestilo 1Obvestilo 2Obvestilo 3
24.10.2019301-263/2019Stryker GmbH, ŠvicaSliding Core UHMPWE
24.10.2019301-264/2019EUROGINE, S.L., SpainIntrauterine Device IUD Eurogine
25.10.2019301-265/2019Integra LifeSciences (Ireland) LtdCUSA Clarity Console
Obvestilo 1Obvestilo 2
25.10.2019301-266/2019Allergan, USAXEN Glaucoma Treatment System
25.10.2019301-267/2019Maquet Cardiopulmonary GmbH, GermanyQUADROX-iD Pediatric with BIOLINE Coating
29.10.2019301-268/2019Philips Medical Systems, USAHeartStart XL+ Defibrillator/Monitor
29.10.2019301-269/2019Bard Peripheral Vascular Inc, USABard® MaxCore® Disposable Core Biopsy Instrument
29.10.2019301-270/2019bioM├ęrieux SA, FranceCetrimide Agar
30.10.2019301-234/2019Abbott, DE03R65-01: Alinity i Processing Module
03R67-01: Alinity c Processing Module
Posodobljeno varnostno obvestilo
30.10.2019301-271/2019arcomed ag, SwitzerlandSyramed ╬╝SP6000
Volumed ╬╝VP7000
30.10.2019301-272/2019Roche Diagnostics GmbH, GermanyElecsys Troponin T hs, Elecsys Troponin T hs STAT
30.10.2019301-273/2019Philips Medical Systems, USAHeartStart XL+ Defibrillator/Monitor
31.10.2019301-274/2019Covidien llc, ZDA303000 Genius 2 Tympanic Thermometer (discontinued)
303013 Genius 3 Tympanic Thermometer
31.10.2019301-217/2019Roche Diabetes Care GmbH, DEAccu-Chek® Insight
Obvestilo 1Obvestilo 2Obvestilo 3
31.10.2019301-275/2019Medtronic Navigation, Inc., ZDA Passive Biopsy Needle Kit
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