{"id":10640,"date":"2025-03-24T15:03:19","date_gmt":"2025-03-24T12:03:19","guid":{"rendered":"https:\/\/www.anm.ro\/en\/?page_id=10640"},"modified":"2025-08-04T09:05:04","modified_gmt":"2025-08-04T06:05:04","slug":"sumarul-notificarilor-in-materie-de-siguranta-in-teren-noiembrie-2024","status":"publish","type":"post","link":"https:\/\/www.anm.ro\/en\/sumarul-notificarilor-in-materie-de-siguranta-in-teren-noiembrie-2024\/","title":{"rendered":"Summary of field safety notifications \/ NOVEMBER 2024"},"content":{"rendered":"

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

USER INFORMATION<\/strong>
\nConexiunile terminalelor sistemelor RM \u00een unitatea general\u0103 de distribu\u0163ie a re\u0163elei\/ manufacturer Philips Medical Systems Nederland B.V., China
\nRef. ANMDMR: 303.008\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nMas\u0103 chirurgical\u0103 de precizie PST 500 U\/ manufacturer Baxter Medical Systems GmbH + Co. KG, Germania
\nRef. ANMDMR: 304.133\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nActualizare privind lansarea solu\u0163iei software \/ manufacturer Philips Goldway (Shenzhen) Industrial Inc., China
\nRef. ANMDMR: 304.872\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\n Mas\u0103 de opera\u021bie: TruSystem 7000\/ manufacturer Baxter Medical Systems GmbH + Co. KG, Germania
\nRef. ANMDMR: 305.990\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nVIDAS\u00ae CK-MB \/ manufacturer bioM\u00e9rieux SA, Fran\u021ba
\nRef. ANMDMR: 306.152\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nL\u0103mpi chirurgicale Merivaara Q-Flow\/ manufacturer Merivaara Corporation, Finlanda
\nRef. ANMDMR: 306.216\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nCatetere PowerPICCsingle lumen 4Fr \/ manufacturer Bard Access Systems, Inc, SUA
\nRef. ANMDMR: 306.695\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nBD BACTEC\u2122 Blood Culture System, BD Phoenix\u2122 M50 Automated
\nMicrobiology System, BD MAX\u2122 System, BD COR\u2122 System, BD EpiCenter\u2122 Microbiology Data
\nManagement System, BD Synapsys\u2122 Informatics Solution \/ manufacturer Becton, Dickinson and Company, SUA
\nRef. ANMDMR: 306.735\/24<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nSELUTION SLR\u2122 018 PTA 3.0mm X 100mm Balloon Catheters\/ manufacturer M.A. Med Alliance SA (MedAlliance), Elve\u021bia
\nRef. ANMDMR: 306.766\/24<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nLovo and Lovo Med Cell Processing System Primary Kits \/ manufacturer Fresenius Kabi AG, Germania
\nRef. ANMDMR: 306.819\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nMiniCap Extended Life PD transfer \/ manufacturer Baxter Healthcare SA, Elve\u021bia
\nRef. ANMDMR: 306.820\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nRocheDiabetes\u00ae Care Platform \/ Accu-Chek\u00ae Care \/ manufacturer Roche Diabetes Care GmbH, Germania
\nRef. ANMDMR: 306.821\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSisteme externe de drenaj \u0219i monitorizare (EDMS) Becker \u0219i Exacta\/ manufacturer Medtronic Inc., SUA
\nRef. ANMDMR: 306.822\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nACURATE neo2TM and ACURATE PrimeTM Aortic Valve Systems\/ manufacturer Boston Scientific Corporation, SUA
\nRef. ANMDMR: 306.823\/24<\/span><\/a>, 306.823C\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nHomocysteine Enzymatic Assay\/ manufacturer Roche Diagnostics GmbH, Germania
\nRef. ANMDMR: 306.860\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nID MEDICS \/ manufacturer ID GmbH & Co. KGaA, Germania
\nRef. ANMDMR: 306.861\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nRadiology software: mint lesion \/ manufacturer Mint Medical GmbH, Germania
\nRef. ANMDMR: 306.862\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nWEINMANN MEDUMAT Transport and MEDUMAT Standard\u00b2 ventilators with CO2 measurement \/ manufacturer WEINMANN Emergency Medical Technology GmbH+Co.KG, Germania
\nRef. ANMDMR: 306.883\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSisteme Proteus XR\/a \/ manufacturer GE Medical Systems SCS, Franta
\nRef. ANMDMR: 306.884\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSubstrat Access \/ manufacturer Beckman Coulter, SUA
\nRef. ANMDMR: 306.894\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nActualizare instruc\u021biuni de utilizare dispozitiv Thoraflex Hybrid \/ manufacturer Vascutek Ltd, Marea Britanie
\nRef. ANMDMR: 306.922\/24<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nDFH-1028, Handle Assy, Single-Use\/ manufacturer MicroSurgical Technology, Inc., SUA
\nRef. ANMDMR: 306.936\/24<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nELUTION SLRTM 018 PTA 3.00 mm \u00d7 100 mm Balloon Catheter\/ manufacturer M.A. Med Alliance SA (MedAlliance), Elve\u021bia
\nRef. ANMDMR: 307.019\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSistem de plasmaferez\u0103 Aurora \/ manufacturer Fresenius Kabi AG, Germania
\nRef. ANMDMR: 307.020\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nEssenz Heart-Lung Machine (HLM) with Software Version HLM.1.5 \/ manufacturer LivaNova Deutschland GmbH, Germania
\nRef. ANMDMR: 307.027\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nOlympus OFP-2 Flushing Pump \/ manufacturer Olympus KeyMed, Marea Britanie
\nRef. ANMDMR: 307.028\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nMEDUMAT Standard 2 with CO2 measurement, emergency and transport ventilator \/ manufacturer WEINMANN Emergency Medical Technology GmbH + Co. KG, Germania
\nRef. ANMDMR: 307.055\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nAplica\u021bia software SynchroMed\u2122 A810 de programare pentru clinician v2.x. \/ manufacturer Medtronic, Inc., SUA
\nRef. ANMDMR: 307.129\/24<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nBIORAPTOR PK Suture Anchors \/ manufacturer Smith & Nephew, Inc., SUA
\nRef. ANMDMR: 307.130\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nCitometru \u00een flux BD FACSLyric\u2122 \/ manufacturer Becton, Dickinson and Company, SUA
\nRef. ANMDMR: 307.131\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nKit de reactivi hsTnI Access \/ manufacturer Immunotech S.A.S., Fran\u021ba
\nRef. ANMDMR: 307.167\/24<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nAccu-Chek\u00ae Spirit 3.15 ml cartridge system: Potential of insulin leakage \/ manufacturer Roche Diabetes Care GmbH, Germania
\nRef. ANMDMR: 307.171\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nOphthalmic Viscosurgical Device (OVD) \/ manufacturer Hyaltech Ltd, Marea Britanie
\nRef. ANMDMR: 307.175\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nVIDAS\u00ae CK-MB \/ manufacturer bioM\u00e9rieux, Franta
\nRef. ANMDMR: 307.270\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nBobine pentru s\u00e2n sistem RM Philips \/ manufacturer Philips Healthcare, Olanda
\nRef. ANMDMR: 307.271\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nInspection and Cleaning of pump exterior components in Aurora Plasmapheresis
\nSystem \/ manufacturer Fresenius Kabi AG, Germania
\nRef. ANMDMR: 307.274\/24<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nVacuum mixer for vertebroplasty cements: Synimix \/ manufacturer Synergie Ing\u00e9nierie Medicale, Franta
\nRef. ANMDMR: 307.277\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nBattery corpuls aed \/ manufacturer GS Elektromedizinische Ger\u00e4te G. Stemple GmbH, Germania
\nRef. ANMDMR: 307.358\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nArthrex SynergyRF System \/ manufacturer Arthrex INC, SUA
\nRef. ANMDMR: 307.362\/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 \/ NOVEMBER 2024 USER INFORMATION Conexiunile terminalelor sistemelor RM \u00een unitatea general\u0103 de distribu\u0163ie a […]<\/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-10640","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\/10640","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=10640"}],"version-history":[{"count":3,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/posts\/10640\/revisions"}],"predecessor-version":[{"id":10948,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/posts\/10640\/revisions\/10948"}],"wp:attachment":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/media?parent=10640"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/categories?post=10640"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/tags?post=10640"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}