{"id":10427,"date":"2024-10-07T16:02:25","date_gmt":"2024-10-07T13:02:25","guid":{"rendered":"https:\/\/www.anm.ro\/en\/?page_id=10427"},"modified":"2025-08-04T09:54:33","modified_gmt":"2025-08-04T06:54:33","slug":"sumarul-notificarilor-in-materie-de-siguranta-in-teren-iunie-2024","status":"publish","type":"post","link":"https:\/\/www.anm.ro\/en\/sumarul-notificarilor-in-materie-de-siguranta-in-teren-iunie-2024\/","title":{"rendered":"Summary of field safety notifications \/ JUNE 2024"},"content":{"rendered":"

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

USER INFORMATION<\/strong>
\nSTANDARDTM F2400 Analyzer \/ manufacturer SD BIOSENSOR, Inc., Coreea
\nRef. ANMDMR: 303.402\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nAll BiPAP A30, BiPAP A30 EFL, BiPAP A30 Hybrid, BiPAP A40, BiPAP A40 EFL, BiPAP A40 Pro Ventilators \/ manufacturer Respironics, Inc., SUA
\nRef. ANMDMR: 303.403\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nC\u0103rucior cu \u00een\u0103l\u0163ime reglabil\u0103 (HA) FlexTrak \/ manufacturer Philips Medical Systems Nederland B.V., Olanda
\nRef. ANMDMR: 303.404\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nMUTARS\u00ae RS stems and MUTARS\u00ae RS Extension pieces \/ manufacturer Implantcast GmbH, Germania
\nRef. ANMDMR: 303.442\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nImunoglobulina M (IgM) \/ manufacturer Beckman Coulter Ireland Inc., Irlanda
\nRef. ANMDMR: 303.449\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nORBIS Medication 3.x \/ manufacturer DH Healthcare GmbH, Germania
\nRef. ANMDMR: 303.492\/24<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nAqualine family of tubing sets for Aquarius System \/ manufacturer Haemotronic S.p.A., Italia
\nRef. ANMDMR: 303.495\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nOmniLab Advanced + (OLA+) ventilators \/ manufacturer Respironics, Inc., SUA
\nRef. ANMDMR: 303.515\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nBD BBL\u2122 Sensi-Disc\u2122 \/ manufacturer Becton, Dickinson and Company, SUA
\nRef. ANMDMR: 303.593\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSYNCHRO Guidewires \/ manufacturer Stryker Neurovascular, SUA
\nRef. ANMDMR: 303.596\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nRocheDiabetes\u00ae Care Platform \/ manufacturer Roche Diabetes Care GmbH, Germania
\nRef. ANMDMR: 303.616\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nCholesterol \/ manufacturer Thermo Fisher Scientific Oy, Finlanda
\nRef. ANMDMR: 303.617\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nDefibrilator extern automat BeneHeart C \/ manufacturer Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
\nRef. ANMDMR: 303.618\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nHintermann Series H3 Total Ankle Replacement System \/ manufacturer DT MedTech, LLC, A Vilex Company, SUA
\nRef. ANMDMR: 303.625\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nQIAcube\u00ae Connect MDx instrument \/ manufacturer QIAGEN GmbH, Germania
\nRef. ANMDMR: 303.648\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nReal Intelligence CORI \/ manufacturer Blue Belt Technologies, Inc., SUA
\nRef. ANMDMR: 303.650\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nVIDAS\u00ae FPSA \/ manufacturer bioM\u00e9rieux SA, Franta
\nRef. ANMDMR: 303.687\/24<\/span><\/a> <\/p>\n

USER INFORMATION<\/strong>
\nBIOFIRE\u00ae FILMARRAY\u00ae Pneumonia and Pneumonia Panel plus \/ manufacturer BioFire Diagnostics, LLC, SUA
\nRef. ANMDMR: 303.688\/24<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nMarimer inhala\u021bii, apa de mare hipertonica 2,2% 30 x 5 mL \/ manufacturer Laboratoires Gilbert, Franta
\nRef. ANMDMR: 303.690\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nOpera T90-SH, Opera T90-SHX \/ manufacturer GMM General Medical Merate SPA, Italia
\nRef. ANMDMR: 303.691\/24<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nSetpack\u00ae Sterile surgical jersey (made from cotton), Kitpacks containing the jersey component \/ manufacturer Lohmann & Rauscher International GmbH & Co.KG, Germania
\nRef. ANMDMR: 303.692\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nCALiaGold\u00ae pierceTube \/ manufacturer SENTINEL CH. S.p.A., Italia
\nRef. ANMDMR: 303.710\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nAXIOM MULTIX MT, AXIOM MULTIX MP, AXIOM Vertix MD, AXIOM Vertix Solitaire, MULTIX Swing, MULTIX TOP Systems \/ manufacturer Siemens Healthcare GmbH, Germania
\nRef. ANMDMR: 303.756\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nBeneHeart D1 Automated External Defibrillator \/ manufacturer SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD., China
\nRef. ANMDMR: 303.757\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nHorizon X-Ray Bone Densitometer (DXA) \/ manufacturer Hologic, Inc., SUA
\nRef. ANMDMR: 303.758\/24<\/span><\/a><\/p>\n

USER INFORMATION <\/strong>
\nSIGNA\u2122 Architect, SIGNA\u2122 Pioneer, SIGNA\u2122 Hero, SIGNA\u2122 Premier, 3.0T SIGNA\u2122 HDxt Family, Discovery MR750 3.0T, Discovery MR750w 3.0T, SIGNA\u2122 PET\/MR, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA\u2122 Artist, SIGNA\u2122 Voyager, 1.5T SIGNA\u2122 HDxt Family, SIGNA\u2122 Creator, SIGNA\u2122 Explorer, SIGNA\u2122 MR380, SIGNA\u2122 MR355, SIGNA\u2122 MR360, Brivo MR355, Optima MR360, SIGNA\u2122 Prime, SIGNA\u2122 Victor, SIGNA\u2122 UHP, Discovery MR950, SIGNA\u2122 7.0T, SIGNA\u2122 MAGNUS \/ manufacturer GE Medical Systems LLC, SUA
\nRef. ANMDMR: 303.759\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nVentilator Leoni plus HFO, Leoni plus Transport \/ manufacturer L\u00f6wenstein Medical SE & Co. KG, Germania
\nRef. ANMDMR: 303.795\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSisteme RMN supraconductoare Vantage Titan MRT-1504, Vantage Titan MRT- 2004, Vantage Titan (Helios) MRT-1504, Vantage Elan MRT-2020, Vantage Orian MRT-1550, Vantage Orian Vantage Fortian MRT- 1550, Vantage Orian (XGO) MRT-1550 \/ manufacturer Canon Medical Systems Corporation, Japonia
\nRef. ANMDMR: 303.796\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nAlinity hq Analyzer \/ manufacturer Abbott Laboratories, SUA
\nRef. ANMDMR: 303.863\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nWired Avalon Ultrasound Transducer \/ manufacturer Philips Medizin Systeme B\u00f6blingen GmbH, Germania
\nRef. ANMDMR: 303.865\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nLDH-P, opt. DGKC \/ manufacturer DIALAB – Produktion und Vertrieb von chemisch-technischen Produkten und Laborinstrumenten Gesellschaft m.b.H., Austria
\nRef. ANMDMR: 303.866\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nPiccolo\u00ae General Chemistry 13\/ manufacturer Abaxis, Inc., SUA
\nRef. ANMDMR: 303.886\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nPapaina \/ manufacturer DIALAB – Produktion und Vertrieb von chemisch-technischen Produkten und Laborinstrumenten Gesellschaft m.b.H., Austria
\nRef. ANMDMR: 303.905\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nNADAL\u00ae Troponin I Test \/ manufacturer nal von minden GmbH, Germania
\nRef. ANMDMR: 304.063\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nExoplan \/ manufacturer exocad GmbH, Germania
\nRef. ANMDMR: 304.065\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nWireless Footswitch Model TFL-AFSWL for Soltive Models Pro TFL-SLS and Premium TFL-PLS \/ manufacturer Gyrus ACMI, Inc. (Olympus Surgical Technologies America), SUA
\nRef. ANMDMR: 304.067\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nLampi chirurgicale iLED 7 \/ manufacturer Baxter Medical Systems GmbH +Co. KG, Germania
\nRef. ANMDMR: 304.074\/24<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nCapioTM SLIM – Dispozitiv de prindere a suturilor \/ manufacturer Boston Scientific Corporation, SUA
\nRef. ANMDMR: 304.077\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nCentricity High Acuity Anesthesia (CHA A) \/ manufacturer GE Healthcare Finland Oy, Finlanda
\nRef. ANMDMR: 304.091\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSistem de monitorizare a nervilor NIM Vital\u2122 \/ manufacturer Medtronic Xomed, Inc., SUA
\nRef. ANMDMR: 304.103\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nMonitor defibrilator DEFIGARD Touch7 \/ manufacturer SCHILLER MEDICAL, Franta
\nRef. ANMDMR: 304.281\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nVentilatoare Puritan Bennett\u2122 seria 500 \/ manufacturer Covidien llc, SUA
\nRef. ANMDMR: 304.282\/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 \/ JUNE 2024 USER INFORMATION STANDARDTM F2400 Analyzer \/ manufacturer SD BIOSENSOR, Inc., Coreea Ref. […]<\/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-10427","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\/10427","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=10427"}],"version-history":[{"count":3,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/posts\/10427\/revisions"}],"predecessor-version":[{"id":10446,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/posts\/10427\/revisions\/10446"}],"wp:attachment":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/media?parent=10427"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/categories?post=10427"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/tags?post=10427"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}