{"id":10432,"date":"2024-10-07T16:03:33","date_gmt":"2024-10-07T13:03:33","guid":{"rendered":"https:\/\/www.anm.ro\/en\/?page_id=10432"},"modified":"2025-08-04T09:53:22","modified_gmt":"2025-08-04T06:53:22","slug":"sumarul-notificarilor-in-materie-de-siguranta-in-teren-aprilie-2024","status":"publish","type":"post","link":"https:\/\/www.anm.ro\/en\/sumarul-notificarilor-in-materie-de-siguranta-in-teren-aprilie-2024\/","title":{"rendered":"Summary of field safety notifications \/ APRIL 2024"},"content":{"rendered":"

SUMMARY OF FIELD SAFETY NOTIFICATIONS \/ APRIL 2024<\/strong><\/p>\n

USER INFORMATION<\/strong>
\nTrilogy Evo, Trilogy Evo O2, Trilogy EV300 \/ manufacturer Philips Respironics Inc., SUA
\nRef. ANMDMR: 301.607\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nMR Systems \/ manufacturer Philips Healthcare, Olanda
\nRef. ANMDMR: 301.987\/24<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nAirvo 2 Humidifier, myAirvo 2 Humidifier \/ manufacturer Fisher & Paykel Healthcare Ltd., Noua Zeelanda
\nRef. ANMDMR: 301.989\/24<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nLASER Application Instrument 23 cm, LEUNIG-GREVERS LASER Application \/ manufacturer KARL STORZ SE & Co. KG, Germania
\nRef. ANMDMR: 301.990\/24<\/span><\/a><\/p>\n

USER INFORMATION <\/strong>
\nB\u00dcHLMANN GanglioCombi\u00ae MAG ELISA \/ manufacturer B\u00dcHLMANN Laboratories AG, Elvetia
\nRef. ANMDMR: 301.991\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nCalibration Serum Level 3 \/ manufacturer Randox Laboratories Ltd., Marea Britanie
\nRef. ANMDMR: 301.994\/24<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nVACSIII 22×40 Percutaneous Transluminal Valvuloplasty Catheter \/ manufacturer OSYPKA AG, Germania
\nRef. ANMDMR: 302.043\/24 <\/span><\/a><\/p>\n

USER INFORMATION <\/strong>
\nTrilogy Evo, Trilogy Evo 02, Trilogy Evo Universal, Trilogy EV300 \/ manufacturer Philips Respironics, Inc., SUA
\nRef. ANMDMR: 302.044\/24 <\/span><\/a><\/p>\n

USER INFORMATION <\/strong>
\nTrilogy Evo O2, Trilogy Evo Universal, Trilogy EV300 \/ manufacturer Philips Respironics, Inc., SUA
\nRef. ANMDMR: 302.045\/24 <\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nKit tampon pentru Clisis Systems, EIDOS RF439, Discovery RF180 \/ manufacturer General Medical Merate S.p.A., Italia
\nRef. ANMDMR: 302.049\/24 <\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nPressio\u00ae ventricular tunnelling catheter kit: PSO-VT, PSO-VTT \/ manufacturer SOPHYSA, Franta
\nRef. ANMDMR: 302.120\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nEvidence MultiSTAT \/ manufacturer Randox Laboratories Ltd., Marea Britanie
\nRef. ANMDMR: 302.121\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nTempus LS \/ manufacturer SCHILLER AG, Elvetia
\nRef. ANMDMR: 302.165\/24<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nRadialis Needle Arrow\u00ae QuickFlash\u00ae Radial Artery Catheterization Kit \/ manufacturer Arrow International LLC Subsidiary of Teleflex Incorporated, SUA
\nRef. ANMDMR: 302.166\/24<\/span><\/a><\/p>\n

USER INFORMATION <\/strong>
\nBiPAP A30, BiPAP A30 EFL, BiPAP A30 Hybrid, BiPAP A40, BiPAP A40 EFL, BiPAP A40 Pro \/ manufacturer Respironics, Inc., SUA
\nRef. ANMDMR: 302.227\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nCARDIOHELP-i \/ manufacturer Maquet Cardiopulmonary GmbH, Germania
\nRef. ANMDMR: 302.228\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nORBIS Medication \/ manufacturer DH Healthcare GmbH, Germania
\nRef. ANMDMR: 302.233\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nTrilogy Evo, Trilogy Evo O2, Trilogy EV300 \/ manufacturer Respironics, Inc. Pittsburgh, SUA
\nRef. ANMDMR: 302.274\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nTub de traheotomie din PVC siliconizat Portex \u2122 Blue Line \/ manufacturer Smiths Medical, SUA
\nRef. ANMDMR: 302.423\/24 <\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nBipolar Pacing Catheter Spike Flow \/ manufacturer Bioptimal International PTE. LTD., Singapore
\nRef. ANMDMR: 302.444\/24 <\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nExactech Optetrak Patella \/ manufacturer Exactech, Inc., SUA
\nRef. ANMDMR: 302.464\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nDeepUnity Diagnost \/ manufacturer DH Healthcare GmbH, Germania
\nRef. ANMDMR: 302.529\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nHistoCore Pegasus, HistoCore Pegasus Plus Systems \/ manufacturer Leica Biosystems Nussloch GmbH, Germania
\nRef. ANMDMR: 302.530\/24 <\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSursa de alimentare neintreruptibila (UPS) a Patient Information Center (PIC) iX \/ manufacturer Philips Medical Systems, SUA
\nRef. ANMDMR: 302.540\/24 <\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nHeartSine\u00ae Samaritan\u00ae PAD 350P\/360P\/450P\/500P, Omron HDF-3500 \/ manufacturer HeartSine Technologies, Ltd. (Stryker Medical), Marea Britanie
\nRef. ANMDMR: 302.541\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSisteme ecografice seria 5000 Compact \/ manufacturer Philips Ultrasound, LLC, SUA
\nRef. ANMDMR: 302.542\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nAplica\u021bia StealthStation\u2122 S8 \/ manufacturer Medtronic Navigation Inc., SUA
\nRef. ANMDMR: 302.548\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nMasks with magnets: Mojo, Mojo 2, iQ 2 and Phantom 2 \/ manufacturer Sleepnet Corporation, SUA
\nRef. ANMDMR: 302.549\/24 <\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nVITELENE INSERT F 32MM POST.WALL, VITELENE INSERT F 36MM POST.WALL \/ manufacturer Aesculap AG, Germania
\nRef. ANMDMR: 302.550\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nProBP 3400, Spot Vision Screener and Power Cords \/ manufacturer Welch Allyn, Inc., SUA
\nRef. ANMDMR: 302.555\/24 <\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nHeart pumps: Impella 5.5 SmartAssist; Impella CP SmartAssist; Impella CP; Impella RP; Impella 5.0; Impella LD, Impella 2.5 \/ manufacturer Abiomed Inc., SUA
\nRef. ANMDMR: 302.556\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nCliniMACS Prodigy TS 310 \/ manufacturer Miltenyi Biotec B.V. & Co. KG, Germania
\nRef. ANMDMR: 302.557\/24<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nHUMAN HumaMeter A1c Reagent Kit \/ manufacturer Human Gesellschaft f\u00fcr Biochemica und Diagnostica mbH, Germania
\nRef. ANMDMR: 302.579\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nD-Dimer Calibration Set \/ manufacturer Thermo Fisher Scientific Oy, Finlanda
\nRef. ANMDMR: 302.582\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nfabian\u2122 HFO \/ manufacturer Acutronic Medical Systems AG, Elve\u021bia
\nRef. ANMDMR: 302.584\/24<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nElectrosurgical Electrode \/ manufacturer Dongguan QueenMed Equipment Mfg Co. Ltd., China
\nRef. ANMDMR: 302.589\/24<\/span><\/a><\/p>\n

USER INFORMATION <\/strong>
\nVarious Mapleson F Anaesthetic Breathing Systems \/ manufacturer Intersurgical Ltd., Marea Britanie
\nRef. ANMDMR: 302.590\/24<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nAffinis Inverse Drill-bit 2.5, Gen2; Affinis Inverse Drill-bit 3.2, Gen2 \/ manufacturer Mathys AG Bettlach, Elve\u021bia
\nRef. ANMDMR: 302.591\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nCGM CLINICAL Medication \/ manufacturer CompuGroup Medical Software GmbH, Germania
\nRef. ANMDMR: 302.594\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nVaporizer Sevoflurane Maquet filling, Vaporizer Sevoflurane SAFE-T-SEAL, Vaporizer Sevoflurane Quik-Fil \/ manufacturer Maquet Critical Care AB, Suedia
\nRef. ANMDMR: 302.603\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSistemul Incisive CT\/CT 3500\/CT 5300 \/ manufacturer Philips Healthcare (Suzhou) Co., Ltd, China
\nRef. ANMDMR: 302.607\/24<\/span><\/a><\/p>\n

USER INFORMATION <\/strong>
\nCGM CLINICAL Medication \/ manufacturer CompuGroup Medical Software GmbH, Germania
\nRef. ANMDMR: 302.612\/24 <\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nEVOLUX \/ manufacturer SIFI S.p.A, Italia
\nRef. ANMDMR: 302.615\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nDuoLys kit \/ manufacturer DIAGAST, Franta
\nRef. ANMDMR: 302.848\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nABD-Lys kit \/ manufacturer DIAGAST, Franta
\nRef. ANMDMR: 302.849\/24<\/span><\/a><\/p>\n

Please note: If you have questions regarding any of the aforementioned information, please contact the issuer of the field safety notification directly.<\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"

SUMMARY OF FIELD SAFETY NOTIFICATIONS \/ APRIL 2024 USER INFORMATION Trilogy Evo, Trilogy Evo O2, Trilogy EV300 \/ manufacturer Philips […]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-10432","post","type-post","status-publish","format-standard","hentry"],"post_mailing_queue_ids":[],"_links":{"self":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/posts\/10432","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/comments?post=10432"}],"version-history":[{"count":3,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/posts\/10432\/revisions"}],"predecessor-version":[{"id":10451,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/posts\/10432\/revisions\/10451"}],"wp:attachment":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/media?parent=10432"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/categories?post=10432"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/tags?post=10432"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}