{"id":10642,"date":"2025-03-24T15:04:03","date_gmt":"2025-03-24T12:04:03","guid":{"rendered":"https:\/\/www.anm.ro\/en\/?page_id=10642"},"modified":"2025-08-04T09:04:23","modified_gmt":"2025-08-04T06:04:23","slug":"sumarul-notificarilor-in-materie-de-siguranta-in-teren-decembrie-2024","status":"publish","type":"post","link":"https:\/\/www.anm.ro\/en\/sumarul-notificarilor-in-materie-de-siguranta-in-teren-decembrie-2024\/","title":{"rendered":"Summary of field safety notifications \/ DECEMBER 2024"},"content":{"rendered":"

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

PRODUCT RECALL<\/strong>
\nAnesthesia system: Flow-i C20, Flow-i C30, Flow-i C40, Flow-c, Flow-e \/ manufacturer Maquet Critical Care AB, Suedia
\nRef. ANMDMR: 302.603\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nBobine SENSE XL Torso (1.5T \u015fi 3.0T) \/ manufacturer Philips Healthcare, Olanda
\nRef. ANMDMR: 304.125\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nTrilogy Evo, Trilogy Evo O2, Trilogy EV300 \/ manufacturer Philips Respironics, Inc., SUA
\nRef. ANMDMR: 306.433\/24<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nDevice intended for preparation of cements: Synimix VTP Mixer System \/ manufacturer Synergie Ing\u00e9nierie Medicale, Fran\u021ba
\nRef. ANMDMR: 307.277c\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSingle-Use Osteochondral Autograft Transfer System \/ manufacturer Arthrex INC, SUA
\nRef. ANMDMR: 307.364\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nTubing set \/ manufacturer Baxter Healthcare SA, Elve\u021bia
\nRef. ANMDMR: 307.365\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nANIOSPRAY QUICK, ANIOS QUICK WIPES \/ manufacturer Laboratoires Anios, Franta
\nRef. ANMDMR: 307.369\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nDENTASEPT SPRAY 60 PRO \/ manufacturer D.M.D, Franta
\nRef. ANMDMR: 307.370\/24<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nDisposable Bipolar Pencil 25GA \/ manufacturer Kirwan Surgical Products LLC, USA
\nRef. ANMDMR: 307.372\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nEZ Glide Aortic Cannulae \/ manufacturer Edwards Lifesciences LLC, USA
\nRef. ANMDMR: 307.375\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nNeonatal ventilator family SOPHIE \/ manufacturer Fritz Stephan GmbH, Germania
\nRef. ANMDMR: 307.380\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nVidas Myoglobine \/ manufacturer bioM\u00e9rieux SA, Franta
\nRef. ANMDMR: 307.383\/24<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nGubisch Osteotom 20cm \/ manufacturer Medicon eG, Germania
\nRef. ANMDMR: 307.402\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nGLUCOSE liquicolor \/ manufacturer Human Gesellschaft f\u00fcr Biochemica und Diagnostica mbH, Germania
\nRef. ANMDMR: 307.407\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nIncorrect display of medication with CGM CLINICAL Medication \/ manufacturer CompuGroup Medical Software GmbH, Germania
\nRef. ANMDMR: 307.410\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nPiezowave 2 Control UNIT \/ manufacturer Richard Wolf GmbH, Germania
\nRef. ANMDMR: 307.481\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nFoley catheters, Prostatic catheters, Urinary diversion devices, Neoplex\u00ae urethral catheters without balloon, Urethral bougies, Urodynamic catheters, Percutaneous nephrostomy catheters, Supra-pubic drainage set, Surgical drainage devices \/ manufacturer Coloplast A\/S, Danemarca
\nRef. ANMDMR: 307.484\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSistem Philips Allura Xper \/ manufacturer Philips Medical Systems Nederland BV, Olanda
\nRef. ANMDMR: 307.486\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nIdylla\u2122 Instrument \/ manufacturer Biocartis NV, Belgia
\nRef. ANMDMR: 307.487\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nKombi \/ manufacturer Physiomed Elektromedizin AG, Germania
\nRef. ANMDMR: 307.493\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\n3M\u2122 Transbond\u2122 Plus Self-Etching Primer \/ manufacturer 3M Unitek Corporation, USA
\nRef. ANMDMR: 307.518\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSingle use Biofill infiltration cannula \/ manufacturer Human Med AG, Germania
\nRef. ANMDMR: 307.522\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nVITROS\u00ae Chemistry Products DGXN \/ manufacturer QuidelOrtho (Ortho Clinical Diagnostics Inc), SUA
\nRef. ANMDMR: 307.567\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSpeedControl Dial utilized with SmartDrive MX2+ Power Assist Device \/ manufacturer Max Mobility LLC, SUA
\nRef. ANMDMR: 307.568\/24<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nCanule arteriale etichetate gre\u0219it \/ manufacturer Medtronic, Inc., SUA
\nRef. ANMDMR: 307.570\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\n Stimulatoare cardiace bicamerale (DR) cu durat\u0103 de via\u021b\u0103 standard (SL) \u0219i durat\u0103 de via\u021b\u0103 extins\u0103 (EL) ACCOLADE\u2122, PROPONENT\u2122, ESSENTIO\u2122, \u0219i ALTRUA\u2122 2; \u0219i stimulatoare cardiace pentru terapie de resincronizare cardiac\u0103 (CRT-P) VISIONIST\u2122 \u0219i VALITUDE\u2122\/ manufacturer Cardiac Pacemaker Inc, SUA
\nRef. ANMDMR: 307.571\/24<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nSingle Use Mechanical Lithotriptor V \/ manufacturer Olympus Medical Systems Corporation, Japonia
\nRef. ANMDMR: 307.680\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nCompatibilitatea seringii de heparin\u0103 cu aparatele de dializ\u0103: 4008H, 4008B, 4008S, Art(Standard\/Universal), Prometheus \/ manufacturer Fresenius Medical Care AG, Germania
\nRef. ANMDMR: 307.736\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nEvo IQ Large Volumetric Pumps (LVP) \/ manufacturer Baxter Healthcare SA, Elve\u021bia
\nRef. ANMDMR: 307.752\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nRedmount \u2013 mounting bracket Space\/ manufacturer Hestomed GmbH, Germania
\nRef. ANMDMR: 307.753\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nRezultate Serratia marcescens fals pozitive pe panoul BIOFIRE BCID2 atunci c\u00e2nd este utilizat \u00eempreun\u0103 cu anumite loturi de flacoane de cultur\u0103 BACT\/ALERT\u00ae\/ manufacturer BioFire Diagnostics, LLC, USA
\nRef. ANMDMR: 307.754\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\n THUNDERBEAT Type S Hand Instruments \/ manufacturer Olympus Medical Systems Corporation, Japonia
\nRef. ANMDMR: 307.755\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nCartu\u0219 BD PCR \/ manufacturer Becton, Dickinson and Company, USA
\nRef. ANMDMR: 307.757\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nMSOT Acuity Echo CE, MSOT Acuity Research Systems, MSOT Acuity Echo Research Systems \/ manufacturer \/ iThera Medical GmbH, Germania
\nRef. ANMDMR: 307.768\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nFigulla Flex II ASD and its Procedure Pack \/ manufacturer Occlutech GmbH, Germania
\nRef. ANMDMR: 307.769\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nInfinia, VariCam\/VG\/VH, Brivo NM 615, Discovery NM 630, Discovery NM\/CT 670, and Optima NM\/CT 640 Nuclear Medicine systems \/ manufacturer GE Medical Systems Israel, Functional Imaging, Israel
\nRef. ANMDMR: 307.770\/24<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nNobel Biocare N1 TiUltra Implants \/ manufacturer Nobel Biocare AB, Suedia
\nRef. ANMDMR: 307.773\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nBeneFusion nSP syringe pumps \/ manufacturer Shenzhen Mindray Scientific Co., Ltd., China
\nRef. ANMDMR: 307.774\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSingle Use Mechanical Lithotriptor V \/ manufacturer Olympus Medical Systems Corporation, Japonia
\nRef. ANMDMR: 307.779\/24<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nFABCO Ivalon eye wicks, cellulose surgical spears and anatomical nasal pack with tube \/ manufacturer Medsorb Dominicana S.A., Republica Dominican\u0103
\nRef. ANMDMR: 307.780\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSirolimus Eluting Coronary Stent System \/ manufacturer Translumina GmbH, Germania
\nRef. ANMDMR: 307.783\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nBORA UP 2080 OP 230V 50\/60 Hz \/ manufacturer ATMOS MedizinTechnik GmbH & Co. KG, Germania
\nRef. ANMDMR: 307.785\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nVaporizatoare : Tec 6 Plus \u0219i Tec 800 \/ manufacturer Datex-Ohmeda, Inc, USA
\nRef. ANMDMR: 307.786\/24<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nSterile Ophthalmic surgical sets: TRUPACK\u00ae \/ manufacturer Trusetal Verbandstoffwerk GmbH, Germania
\nRef. ANMDMR: 307.790\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nForceps\/Irrigation Plug (Isolated Type) \/ manufacturer
\nRef. ANMDMR: 72\/25<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nDeltaCut Biopsy – extraction of tissue specimen \/ manufacturer PAJUNK GmbH Medizintechnologie, Germania
\nRef. ANMDMR: 80\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nUltrasound Surgical Unit \/ manufacturer Olympus Medical Systems Corporation, Japonia
\nRef. ANMDMR: 147\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nStent cu Sistem de introducere cu electrocauter AXIOS\u2122 \/ manufacturer Boston Scientific Corporation, USA
\nRef. ANMDMR: 163\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nReagent Expired (RE) Result Code Potentially Not Being Produced When Signal Reagent (SR)Pack Is Expired on VITROS\u00ae 3600, 5600 and XT 7600 Systems \/ manufacturer QuidelOrtho (Ortho Clinical Diagnostics Inc), USA
\nRef. ANMDMR: 382\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nVIDAS\u00ae CK-MB \/ manufacturer bioM\u00e9rieux SA, Fran\u021ba
\nRef. ANMDMR: 384\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nDifuzoare Edifier \/ manufacturer Draeger Medical System, Inc., SUA
\nRef. ANMDMR: 386\/25<\/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 \/ DECEMBER 2024 PRODUCT RECALL Anesthesia system: Flow-i C20, Flow-i C30, Flow-i C40, Flow-c, Flow-e […]<\/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-10642","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\/10642","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=10642"}],"version-history":[{"count":2,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/posts\/10642\/revisions"}],"predecessor-version":[{"id":10657,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/posts\/10642\/revisions\/10657"}],"wp:attachment":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/media?parent=10642"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/categories?post=10642"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/tags?post=10642"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}