{"id":10430,"date":"2024-10-07T16:02:50","date_gmt":"2024-10-07T13:02:50","guid":{"rendered":"https:\/\/www.anm.ro\/en\/?page_id=10430"},"modified":"2025-08-04T09:53:34","modified_gmt":"2025-08-04T06:53:34","slug":"sumarul-notificarilor-in-materie-de-siguranta-in-teren-mai-2024","status":"publish","type":"post","link":"https:\/\/www.anm.ro\/en\/sumarul-notificarilor-in-materie-de-siguranta-in-teren-mai-2024\/","title":{"rendered":"Summary of field safety notifications \/ MAY 2024"},"content":{"rendered":"

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

USER INFORMATION <\/strong>
\nKit de cateter cu balon intra-aortic Arrow\u00ae FiberOptix\u2122, Kit de cateter cu balon intra-aortic Arrow\u00ae UltraFlex\u2122 \/ manufacturer Arrow International LLC (Subsidiary of Teleflex Incorporated), SUA
\nRef. ANMDMR: 302.648\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nCareEvent & Patient Information Center iX (PlC iX) \/ manufacturer Philips Medical Systems, SUA
\nRef. ANMDMR: 302.676\/24<\/span><\/a><\/p>\n

USER INFORMATION\t<\/strong>
\nTempus LS \/ manufacturer SCHILLER AG, Elve\u021bia
\nRef. ANMDMR: 302.683\/24<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nSyntel\u00ae Silicone Thrombectomy Catheter \/ manufacturer LeMaitre Vascular, Inc, SUA
\nRef. ANMDMR: 302.684\/24<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nVITELENE INSERT F32MM POST.WALL, VITELENE INSERT I 36MM POST.WALL \/ manufacturer Aesculap AG, Germania
\nRef. ANMDMR: 302.685\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nPatient Information Center(PIC) iX Uninterruptable Power Supply (UPS) Failures \/ manufacturer Philips Medical Systems, SUA
\nRef. ANMDMR: 302.686\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nHistoCore Pegasus, HistoCore Pegasus Plus \/ manufacturer Leica Biosystems Nussloch GmbH, Germania
\nRef. ANMDMR: 302.689\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nEcofit S, Ecofit S Low, Ecofit S Plus, Ecofit S Low Plus, Ecofit Plus, Ecofit Plus Low, Ecofit S Comfort \/ manufacturer Tecfor care GmbH, Germania
\nRef. ANMDMR: 302.690\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nMiSeq\u2122 Dx Instrument, NextSeq\u2122 550Dx Instrument, NovaSeq\u2122 6000Dx Instrument, Illumina DRAGEN\u2122 Server for NextSeq\u2122 550Dx, Illumina DRAGEN\u2122 Server v4, VeriSeq\u2122 Onsite Server v2 \/ manufacturer Illumina, Inc., SUA
\nRef. ANMDMR: 302.691\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nPhosphorus Inorganic, Molybdate \/ manufacturer DIALAB – Produktion und Vertrieb von chemisch-technischen Produkten und Laborinstrumenten Gesellschaft m.b.H., Austria
\nRef. ANMDMR: 302.692\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nCARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE B850 \/ manufacturer GE Healthcare Finland Oy, Finlanda
\nRef. ANMDMR: 302.697\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nBisturiu calibrul 20 MVR+ cu lam\u0103 V-Lance \/ manufacturer Alcon Laboratories, Inc., SUA
\nRef. ANMDMR: 302.738\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nMonitor de sistem \/ manufacturer Thoratec Corporation, SUA
\nRef. ANMDMR: 302.739\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nInstaClear Sheath \/ manufacturer Gyrus ACMI, Inc. (Olympus Surgical Technologies America), SUA
\nRef. ANMDMR: 302.741\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nBD Multitest\u2122 TBNK \u00een 6 culori \/ manufacturer Becton, Dickinson and Company, SUA
\nRef. ANMDMR: 302.795\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\n100380A0 leg holder \/ manufacturer MAQUET GmbH, Germania
\nRef. ANMDMR: 302.852\/24<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nArteriofix kit g\u00f6rlitz, Radialis arteriofix kit gener.hosp.hagen, Arteriofix 20g x 80mm \/ manufacturer B. Braun Melsungen AG, Germania
\nRef. ANMDMR: 302.875\/24<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nVICRYL\u2122 (polyglactin 910) Suture and VICRYL\u2122 Plus Antibacterial (polyglactin 910) Suture, PDS\u2122 II (polydioxanone) Suture and PDS\u2122 Plus Antibacterial (polydioxanone) Suture, MONOCRYL\u2122 (poliglecaprone 25) Suture and MONOCRYL\u2122 Plus Antibacterial (poliglecaprone 25) Suture \/ manufactureri Ethicon Inc., SUA si Johnson & Johnson International, Belgia
\nRef. ANMDMR: 302.950\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nCateter intratecal Ascenda\u2122 model 8780, 8781 \u0219i 8784 \/ manufacturer Medtronic Inc., SUA
\nRef. ANMDMR: 302.951\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nFlycicle Vision \/ manufacturer Dosing GmbH, Germania
\nRef. ANMDMR: 302.952\/24<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nOptima and Prestige Coil Systems \/ manufacturer Balt USA, SUA
\nRef. ANMDMR: 302.953\/24<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nEndo-Model Knee System, LINK Endo-Model EVO Knee System \/ manufacturer Waldemar Link GmbH & Co.KG, Germania
\nRef. ANMDMR: 302.960\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nORBIS Medication 3.x \/ manufacturer DH Healthcare GmbH, Germania
\nRef. ANMDMR: 302.962\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nMultiCut Blade 350, MultiCut Blade 400 \/ manufacturer Asclepion Laser Technologies GmbH, Germania
\nRef. ANMDMR: 302.963\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nMonitoare de pacient BSM-1763, BSM-3562, BSM-3763 \u0219i module de intrare AY-661P \u0219i AY-663P \/ manufacturer NIHON KOHDEN Corporation, Japonia
\nRef. ANMDMR: 302.975\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nCentricity High Acuity Critical Care (CHA CC) Versiunea 5.0 \u0219i cele succesive, cu func\u021bia Order Module (Modul de comenzi) activat\u0103; Centricity High Acuity Anesthesia (CHA A) Versiunea 4.2 \u0219i cele succesive, cu func\u021bia Order Module (Modul de comenzi) activat\u0103 \/ manufacturer GE Healthcare, SUA
\nRef. ANMDMR: 302.978\/24 <\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nDispozitiv de calibrare HbA1c II \/ manufacturer Randox Laboratories, Marea Britanie
\nRef. ANMDMR: 302.984\/24<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nKD-LINE\u00ae Extension-Connection Tubing for connection to infusion and transfusion systems \/ manufacturer KD Medical GmbH Hospital Products, Germania
\nRef. ANMDMR: 302.985\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nAchieva 1.5T, Achieva 1.5T Conversion, Achieva 1.5T Initial system, Achieva 3.0T, Achieva 3.0T pentru PET, Achieva 3.0T TX pentru PET, Achieva XR, Evolution upgrade 1.5T, Evolution upgrade 3.0T, Ingenia 1.5T, Ingenia 1.5T CX, Ingenia 1.5T S, Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Ambition S, Ingenia Ambition X, Ingenia Elition X, INGENUITY TF PET MR, Intera 1.5T, Marlin 1.5T, MR 5300, Sistem RM Marlin de 1,5 T, MR-RT, Upgrade-uri MR-RT, Panorama HFO, SmartPath – dStream pentru 1.5T, SmartPath – dStream pentru 3.0T, SmartPath – dStream pentru XR \u015fi 3.0T, SmartPath to Ingenia Elition X, Sonalleve MR-HIFU 3.0T, Upgrade dStream \/ manufacturer Philips Medical Systems Nederland B.V., Olanda
\nRef. ANMDMR: 303.008\/24<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nPower supply unit for care beds in the Ecofit Xtra range\/ manufacturer tecfor care GmbH, Germania
\nRef. ANMDMR: 303.073\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nVITROS\u00ae Immunodiagnostic Products Anti-HBs Calibrators \/ manufacturer QuidelOrtho (Ortho Clinical Diagnostics Inc), Marea Britanie
\nRef. ANMDMR: 303.074\/24<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nInfusion tube for syringe pumps 150 cm \/ manufacturer Shandong Lee Med Technology Co., Ltd., China
\nRef. ANMDMR: 303.075\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nTotal Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1 on Mako 3.0, 3.1 \/ manufacturer Stryker Joint Replacement, SUA
\nRef. ANMDMR: 303.181\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nConsola principal\u0103 CentriMag de a 2-a genera\u021bie \/ manufacturer Thoratec Switzerland GmbH, Elve\u021bia
\nRef. ANMDMR: 303.184\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nEndo-Model M Modular Knee Prosthesis System, Endo-Model SL Rotational and Hinge Knee Prosthesis System \/ manufacturer Waldemar Link GmbH & Co.KG, Germania
\nRef. ANMDMR: 303.186\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nAESCULAP AEOS System PV010, AESCULAP AEOS System PV010893 \/ manufacturer AESCULAP AG, Germania
\nRef. ANMDMR: 303.188\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nmultiFiltratePRO \/ manufacturer Fresenius Medical Care AG, Germania
\nRef. ANMDMR: 303.189\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nCGM CLINICAL Medication \/ manufacturer CompuGroup Medical Software GmbH, Germania
\nRef. ANMDMR: 303.190\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nORBIS Medication 03.X \/ manufacturer DH Healthcare GmbH, Germania
\nRef. ANMDMR: 303.193\/24<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nE.MOTION PRO \/ manufacturer AESCULAP AG, Germania
\nRef. ANMDMR: 303.194\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nDefibrilator Tempus LS \/ manufacturer Schiller AG, Elve\u021bia
\nRef. ANMDMR: 303.195\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nPIC iX Customized Event Catalog Setting Not Copied as Expected From One Unit to
\nAnother\/ manufacturer Philips Medical Systems, SUA
\nRef. ANMDMR: 303.236\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nInfinity M500 Docking Station \/ manufacturer Draeger Medical Systems, Inc., SUA
\nRef. ANMDMR: 303.278\/24<\/span><\/a><\/p>\n

USER INFORMATION <\/strong>
\nIdylla\u2122 EGFR Mutation Test \/ manufacturer Biocartis, Belgia
\nRef. ANMDMR: 303.285\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nORBIS Medication 03.X \/ manufacturer DH Healthcare GmbH, Germania
\nRef. ANMDMR: 303.290\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nMedi-Test URYXXON\u00ae Stick 10 \/ manufacturer MACHEREY-NAGEL GmbH & Co.KG, Germania
\nRef. ANMDMR: 303.292\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nMedical Ventilator HAMILTON-C6 \/ manufacturer Hamilton Medical AG, Elvetia
\nRef. ANMDMR: 303.296\/24<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nAdvanta VXT and Flixene Vascular Grafts \/ manufacturer Atrium Medical Corporation, SUA
\nRef. ANMDMR: 303.298\/24<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nBiolox\u00ae delta Ceramic Femoral Head, M, 36\/0 taper 12\/14 \/ manufacturer Zimmer Switzerland Manufacturing GmbH, Elve\u021bia
\nRef. ANMDMR: 303.342\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSuprasorb CNP endo Kit Oral \/ manufacturer Lohmann & Rauscher GmbH & Co.KG, Germania
\nRef. ANMDMR: 303.343\/24<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nTLIF & PLIF Implants \/ manufacturer Eit Emerging Implant Technologies GmbH, Germania
\nRef. ANMDMR: 303.344\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nABL800 Basic and ABL8XX FLEX analyzers \/ manufacturer Radiometer Medical ApS, Danemarca
\nRef. ANMDMR: 303.388\/24<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nMC3\u00ae – Femoral semi-wedges-Batch mixing \/ manufacturer C2F IMPLANTS, Franta
\nRef. ANMDMR: 303.389\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nDefibrilator extern automat BeneHeart D1 \/ manufacturer Shenzhen Mindray Bio-Medical Electronics Co., Ltd., China
\nRef. ANMDMR: 303.394\/24<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nTrevo Retrievers\/Microcatheters, FlowGate2, Distal Access Catheter (DAC), Synchro \/ manufacturer Stryker Neurovascular, SUA
\nRef. ANMDMR: 303.397\/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 \/ MAY 2024 USER INFORMATION Kit de cateter cu balon intra-aortic Arrow\u00ae FiberOptix\u2122, Kit de […]<\/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-10430","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\/10430","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=10430"}],"version-history":[{"count":3,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/posts\/10430\/revisions"}],"predecessor-version":[{"id":10449,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/posts\/10430\/revisions\/10449"}],"wp:attachment":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/media?parent=10430"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/categories?post=10430"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/tags?post=10430"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}