Maj

DatumŠtevilka zadeveProizvajalecMedicinski pripomoček
01.04.2025P301-81/2025Fresenius Kabi AG, DE

CompoStop™ Flex 2F – PLT processing and leuko reduction system
CompoStop™ Flex 3F T&B – PLT Pooling system
CompoStop™ Flow-Flex 3F T&B – PLT Pooling system
CompoStop Flow-Flex 3F T&B – PLT Pooling system
FD51600, FD516AB, FT52600, GT52600, GT526NL
04.04.2025P301-85/2025Welch Allyn, Inc., ZDAWelch Allyn Connex Vital Signs Monitor (CVSM),
Welch Allyn CP150 Electrocardiograph,
Welch Allyn Connex Spot Monitor Accessory Power Management Stand (APM)
Varnostno obvestilo
Priloga A
Priloga B
28.10.2024P301-238/2024Bard Access Systems, Inc, ZDA4Fr Single-Lumen PowerPICC SOLO
4Fr Single-Lumen PowerPICC
Posodobitev varnostnega obvestila objavljenega oktobra 2024
Priloga 1
27.03.2025P301-80/2025Datex-Ohmeda, Inc, ZDACarestation 600 and 750 Series
Posodobitev obvestila objavljenega marca 2025
08.04.2025P301-86/2025GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC, ZDAVenue Go, Venue Fit
Posodobitev obvestila objavljenega aprila 2025
30.04.2025P301-105/2025Dexcom, Inc., ZDADexcom G7 iOS CGM App
06.05.2025P301-106/2025ICU Medical Inc; ZDA
CADD-Solis™ Ambulatory Infusion Pumps
06.05.2025P301-107/2025ICU Medical Inc; ZDA
CADD-Solis™ Ambulatory Infusion Pumps
06.05.2025P301-108/2025ICU Medical Inc; ZDA
CADD-Solis™ Ambulatory Infusion Pumps
02.05.2025P301-109/2025Natus Medical Incorporated DBA Excel -Tech Ltd. (XLTEK), CA
Olympic Brainz Monitor (Digital Acquisition Box)
08.05.2025P301-110/2025Cook Endoscopy/Wilson Cook Medical, Inc., ZDA
Instinct Plus Endoscopic Clipping Device
09.05.2025P301-111/20253M Company, ZDA
3M™ Ranger™ Blood/Fluid Warming System
3M™ Ranger™ irrigation fluid warming system
3M™ Ranger™ Blood/Fluid High Flow Warming Disposables
3M™ Ranger™ Fluid Warming Irrigation Set (disposables),
12.05.2025P301-113/2025Olympus Medical Systems Corporation, JP
TJF-Q190V Evis Exera III Duodenovideoscope
TJF-Q290V Evis Lucera Elite Duodenovideoscope
TJF-Q170V Duodenovideoscope
12.05.2025P301-114/2025Spiegelberg GmbH & Co.KG, DE
Silverline Ventrikelsonde mit Schädelschraube ; SND13.1.14S
00.01.1900P301-115/2025BD Switzerland Sàrl, CH
Texium Needle-Free Syringe
Texium Closed Male Luer 
12.05.2025P301-116/2025Beckman Coulter, Inc., ZDASample Probe
13.05.2025P301-117/2025BALT USA,LLC; ZDAOptima Coil System
Varnostno obvestilo
Priloga 1
14.05 2025P301-118/2025Alcon Laboratories, Inc., ZDA
Constellation Total Plus Pak
15.05.2025P301-120/2025
Philips Medical Systems Nederland B.V., NL
Evolution Upgrade 1.5T: 782116, 782148
Evolution Upgrade 3.0T: 782117, 782143
lngenia 1.5T: 781315, 781341, 781396, 782101, 782115, 782140
lngenia 1.5T CX: 781262 lngenia 1.5T S: 781347
lngenia 3.0T: 781342, 781377, 782103
lngenia 3.0T CX: 781271
lngenia Ambition S: 781359, 782108, 782139
lngenia Ambition X: 781356, 782109, 782138
lngenia Elition S: 781357, 782106, 782137
lngenia Elition X: 781358, 782107, 782136
MR 5300: 78211O, 782152
MR 7700: 782120, 782153
SmartPath to dStream for 1.5T: 781260, 782112, 782146 SmartPath to dStream for 3.0T: 782145
SmartPath to dStream for XR and 3.0T: 781270, 782113 SmartPath to lngenia Elition X: 782118, 782144
Upgrade to MR 7700: 782130
15.05.2025P301-121/2025WEINMANN Emergency Medical Technology GmbH + Co. KG, DE
MEDUMAT Standard², mit und ohne CO2 ; 28710-01, 28710-02,28710-03, 28710-04,15983,28980,15946 / 29500, 29300, 9931, 9913, 9895, 9870, 9719, 9410, 9400
19.05.2025P301-123/2025Becton Dickinson and Company, ZDA
BD BACTEC™ MGIT™ 960 PZA Kit
19.05.2025P301-124/2025IntersurgicaL Ltd., GBVarious BVM Resuscitators
21.05.2025P301-126/2025Covidien llc. ZDANewport HT Ventilator with Accessories, Plus model;
Newport HT70™ Plus Ventilator with oxygen monitoring, SpO2 monitoring, onairway flow sensor;
Varnostno obvestilo
Priloga A
Priloga B
22.05.2025P301-127/2025CareDx Pty Ltd, AUSAlloSeq cfDNA
22.05.2025P301-128/2025
Philips Medical Systems Nederland B.V., NL
Philips Hemodynamic Application
23.05.2025P301-129/2025MACOPHARMA, FR
Collection Red cell LCR filter set
22.05.2025P301-130/2025Abbott Ireland Diagnostics Division, IE
Alinity i Total PSA Reagent Kit
26.05.2025P301-131/2025implantcast GmbH, DE
MUTARS® proximal femur (revision)
27.05.2025P301-132/2025Integra LifeSciences Corp, ZDAMicromyst® Applicator
Varnostno obvestilo 1
Varnostno obvestilo 2
28.05.2025P301-133/2025QuidelOrtho (Ortho Clinical Diagnostics Inc), ZDAVITROS Analyser System
30.05.2025P301-134/2025Drägerwerk AG & Co. KGaA
SafeStar Plus, TwinStar HEPA Plus
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