September

DatumŠtevilka zadeve
Proizvajalec		Medicinski pripomoček
21.05.2025P301-125/2025curasonix GmbH, DEcurason
04.06.2025P301-136/2025MEDTRON AG, DE
All consumables from MEDTRON
11.06.2025P301-141/2025DeVilbiss Healthcare LLC, ZDA
iGo2-125 Series Portable Oxygen Concentrator – DC ; 125K, 125K-XB, 125K-BT, 125K-BT-XB / DV6X-619 125 DC Power Adapter:
Drive DeVilbiss Healthcare Car Charger Power Cord Accessory
29.08.2025301-273/2021Datascope Corp. Getinge, ZDACardiosave Intra-Aortic Balloon Pumps
Posodobitev obvestila objavljenega novembra 2021
20.08.2025P301-194/2025Siemens Healthcare GmbH, DE
MAGNETOM
BIOGRAPH
01.09.2025P301-200/2025MedicalCommunications GmbH, DE
Ashvins variant HEYEX 2 / HEYEX PACSversion 2.6.0 (Build 2088) to 2.6.8 (Build 2220)
Ashvins 2020 (Build 1891) until Ashvins 2023 (Build 2229) 
03.09.2025P301-201/2025SCHILLER MEDICAL, FRDEFIGARD HD-7
04.09.2025P301-204/2025SAFE ORTHOPAEDICS
Sterispine PS
KIT of 2 MULTIAXIAL SCREWS 7,5x XYmm
05.09.2025P301-205/2025Siemens Healthcare, ZDA
Atellica CH Urinary/Cerebrospinal Fluid Protein
05.09.2025P301-206/2025LivaNova USA, Inc., ZDA
SenTiva™ VNS Therapy™ Generator
08.09.2025P301-207/2025Olympus Medical Systems Corporation, JP
OLYMPUS BRONCHOFIBERSCOPE, BRONCHOVIDEOSCOPES:
EVIS EXERA II EXERA III EVIS LUCERA ELITE  OES BRONCHOVIDEOSCOPE
BRONCHOFIBERSCOPE
09.09.2025P301-208/2025MicroVention Europe SARL, FRRENZAN™ Peripheral Stent System
RENZAN™ 6F – stents
Obvestilo
Priloga
12.09.2025P301-210/2025Abbott, ZDA
TactiFlex™ Force Sensing Ablation Catheter, SE
TactiFlex SE UniD Curve D, model A-TFSE-D
TactiFlex SE UniD Curve F, model A-TFSE-F
TactiFlex SE BiD Curve F-J, model A-TFSE-FJ
TactiFlex SE BiD Curve D-F, model A-TFSE-DF
TactiFlex SE BiD Curve D-D, model A-TFSE-DD
12.09.2025P301-212/2025Philips Medical Systems Nederland BV, NL
Philips Allura Xper, Allura Centron and CV20
12.09.2025P301-213/2025DiaMed GmbH
ID-Anti-S
ID-Anti-M, N, S, s, Fya, Fyb
15.09.2025P301-214/2025Diagnostic Grifols S.A., ESErytra
17.09.2025P301-215/2025Fisher & Paykel Healthcare Ltd, NZ (SRN NZ-MF-000002556)
AIRVO2 Humidifier / myAIRVO2 Humidifier
17.09.2025P301-217/2025Philips Medical Systems Nederland BV, NLAllura Xper, Allura CV20.
23.09.2025P301-218/2025Fresenius Kabi AG, DECompoFlow 4F
17.09.2025P301-219/2025MicroVention Europe SARL, FR
FRED™& FRED X™Flow Re-Direction Endoluminal Device
23.09.2025P301-221/2025Tekno-Medical Optik-Chirurgie GmbH, DE
ADSON-BROWN TISSUE FORCEPS 12CM
23.09.2025P301-222/2025Abbott Laboratories, ZDAAlinity hq Analyzer
Obvestilo
Priloga
24.09.2025P301-223/2025GeneProof a.s., CZ

GeneProof Cytomegalovirus (CMV) PCR Kit
Affected Component: Calibrator D (LOT 406621D)
26.09.2025P301-224/2025Medtronic Inc., ZDA
12110: DLP Left Heart Vent Catheters, 10 FR
12113: DLP Left Heart Vent Catheters, 13 FR
12115: DLP Left Heart Vent Catheters, 15 FR
29.09.2025P301-225/2025Convatec Ltd, UKNatura+
30.09.2025P301-226/2025Ecolab Deutschland GmbH, DESekumatic NDT
12.09.2025P301-97/2025Philips Medical Systems Nederland B.V., NLIntelliSpace Cardiovascular
Posodobitev obvestila objavljenega aprila 2025
24.09.2025P301-278/2024Imaxeon Pty Ltd, AUMedrad Centargo CT Injection System
Posodobitev obvestila objavljenega decembra 2024
05.09.2025P301-275/2024Cardiac Pacemaker Inc, ZDAACCOLADE™ family: ACCOLADE, PROPONENT™, ESSENTIO™, and ALTRUA™ 2 Standard Life (SL) and Extended Life (EL) pacemakers; and the VISIONIST™
• VALITUDE™ cardiac resynchronization therapy pacemakers (CRT-P)
Posodobitev obvestila objavljenega decembra 2024
08.09.2025P301-175/2025Nipro Corporation, JPSurdial X & Surdial 55Plus
Posodobitev obvestila objavljenega avgusta 2025
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