{"id":10647,"date":"2025-03-24T15:06:16","date_gmt":"2025-03-24T12:06:16","guid":{"rendered":"https:\/\/www.anm.ro\/en\/?page_id=10647"},"modified":"2025-08-04T09:04:03","modified_gmt":"2025-08-04T06:04:03","slug":"sumarul-notificarilor-in-materie-de-siguranta-in-teren-februarie-2025","status":"publish","type":"post","link":"https:\/\/www.anm.ro\/en\/sumarul-notificarilor-in-materie-de-siguranta-in-teren-februarie-2025\/","title":{"rendered":"Summary of field safety notifications \/ FEBRUARY 2025"},"content":{"rendered":"

SUMMARY OF FIELD SAFETY NOTIFICATIONS \/ FEBRUARY 2025<\/strong><\/p>\n

USER INFORMATION<\/strong>
\nAplica\u021bie software Origin Data Management \/ manufacturer Brainlab AG, Germania
\nRef. ANMDMR: 7986\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\n Idylla\u2122 Instrument \/ manufacturer Biocartis NV, Belgia
\nRef. ANMDMR: 7993\/25<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nCanul\u0103 pentru r\u0103d\u0103cin\u0103 aortic\u0103 \/ manufacturer Medtronic, Inc., SUA
\nRef. ANMDMR: 8009\/25<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nControl-A-Flo \/ manufacturer Baxter Healthcare SA, Elve\u021bia
\nRef. ANMDMR: 8090\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nROTEM sigma complete \/ ROTEM sigma complete + hep \/ manufacturer Tem Innovations GmbH, Germania
\nRef. ANMDMR: 8105\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nDexcom G6 Receiver \/ manufacturer Dexcom, Inc., SUA
\nRef. ANMDMR: 9302\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nPosibile scurgeri cauzate de fisuri – VentStar Flex 220, ID Circuit Flex 220, kit circuit de anestezie Flex \/ manufacturer Dr\u00e4gerwerk AG & Co. KGaA, Germania
\nRef. ANMDMR: 11022\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nPanel gastrointestinal (GI) Biofire\u00ae FILMARRAY\u00ae \/ manufacturer BioFire Diagnostics, LLC, SUA
\nRef. ANMDMR: 11026\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nAnalizor de imunologie Access 2 \/ manufacturer Beckman Coulter, SUA
\nRef. ANMDMR: 11283\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nNEVELIA\u00ae \/ manufacturer SYMATESE, Fran\u021ba
\nRef. ANMDMR: 11312\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nOrigin Data Management \/ manufacturer Brainlab AG; Germania
\nRef. ANMDMR: 11890\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nORBIS Medication 3.x \/ manufacturer DH Healthcare GmbH, Germania
\nRef. ANMDMR: 11896\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nAccess Erythropoietin (EPO) \/ manufacturer Beckman Coulter Inc., SUA
\nRef. ANMDMR: 11918\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nUniversal blood culture adapter, LongNeck blood culture adapter \/ manufacturer Sarstedt AG&Co.KG, Germania
\nRef. ANMDMR: 12288\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nPreparation unit PS-10 \/ manufacturer Sysmex Corporation Japan, Japonia
\nRef. ANMDMR: 12290\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nAnti-TPO \/ manufacturer ORGENTEC Diagnostika GmbH, Germania
\nRef. ANMDMR: 12306\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nAnti-TPO \/ manufacturer ORGENTEC Diagnostika GmbH,
\nRef. ANMDMR: 12307\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\n Monitor func\u021bii vitale pacien\u021bi- CMS6000\/CMS6500\/CMS7000
\n\/CMS8000\/CMS9000 \/ manufacturer Contec Medical Systems Co., Ltd., China
\nRef. ANMDMR: 12674\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\n Monitor pacien\u021bi CMS8000 \/ manufacturer Contec Medical Systems Co., Ltd., China
\nRef. ANMDMR: 12724\/25<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nHamilton Medical In2Flow Nasal cannulas \/ manufacturer Hamilton Medical AG, Germania
\nRef. ANMDMR: 12725\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nOrthopilot\u00ae \/ manufacturer Aesculap AG, Germania
\nRef. ANMDMR: 12728\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nVacuum Container \/ manufacturer Deltalab, S.L., Spania
\nRef.: 25001\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nGlucose liquicolor \/ manufacturer Human Gesellschaft f\u00fcr Biochemica und Diagnostica mbH, Germania
\nRef.: 42662\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nQIAsymphony DNA Midi Kit\/ manufacturer QIAGEN GmbH, Germania
\nRef.: 43973\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nBlueDiver Dot Gastritis IgG \/ manufacturer D-Tek s.a, Belgia
\nRef.: 2501131\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nMedline\u2019s Caresets and Sterile Procedure Trays \/ manufacturer Medline International France SAS, Franta
\nRef.: 2501274\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nID DiaCell I-II-III \/ manufacturer DIAMED GmbH, Germania
\nRef.: 2503616\/25<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nPrecision Thin Blades \/ manufacturer Stryker Instruments, SUA
\nRef. 3846155\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nStimulatoare cardiace Assurity\u2122 \u0219i Endurity\u2122 \/ manufacturer Abbott Medical, SUA
\nRef: 125FA\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nLinie de filtru CO2 intubat\u0103 Microstream\u2122 Advance pentru nou-n\u0103scu\u021bi\/sugari \u0219i adul\u021bi\/copii,
\nLinie de filtru CO2 intubat\u0103 Microstream\u2122 Luer pentru adul\u021bi\/copii \u0219i
\nLinie de e\u0219antionare Microstream\u2122 Luer cu adaptor pentru c\u0103ile respiratorii pentru adul\u021bi\/copii \/ manufacturer Covidien llc, SUA
\nRef. : 1432<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nIntelliBridge EC10 Module and IntelliBridge EC5 ID-Module Interfacing with driver
\nED245 Hamilton Block (ACK) \/ manufacturer Philips Medizin Systeme B\u00f6blingen GmbH
\nRef.: 01612\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nErori la sursa de alimentare ne\u00eentreruptibil\u0103 (UPS) a Patient Information Center (PIC) iX \/ manufacturer Philips Medical Systems, SUA
\nRef.: 2024 010\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nManometre neautomatizate Welch Allyn \/ manufacturer Welch Allyn, Inc., SUA
\nRef.: 2024. 071<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nLaguna Bath Seat\/ manufacturer RUSSKA – Ludwig Bertram GmbH, Germania
\nRef.: 02127\/25<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\n ColonicFTRD Set \/ manufacturer Ovesco Endoscopy AG, Germania
\nRef. 02349\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nHamilton Medical Ventilators HAMILTON-C2\/C3
\nwith Neonatal Option \/ manufacturer
\nRef. 02371\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSond\u0103 endotraheal\u0103 pentru intuba\u021bie oral\u0103\/nazal\u0103 \/ manufacturer ICU Medical Inc, SUA
\nRef. 002502-01\/25<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nAPTUS Hand Plate \/ manufacturer Medartis AG, Germania
\nRef.: 02738\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nT2\u2122 Rigid Reamers \/ manufacturer Stryker Trauma GmbH Kiel; Germania
\nRef.: 03160\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nExelia software version \/ manufacturer Fresenius Kai AG, Germania
\nRef.: 03254\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nMedi stream 3000 water massage \/ manufacturer NM Stahlger\u00e4te GmbH, Germania
\nRef. 04143\/25<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nClimber Guiding Catheter \/ manufacturer PendraCare International B.V. Olanda
\nRef.: 04823\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nIntelliBridge EC10 Module \/ manufacturer Philips Medizin Systeme B\u00f6blingen GmbH, Germania
\nRef. : 7359\/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 \/ FEBRUARY 2025 USER INFORMATION Aplica\u021bie software Origin Data Management \/ manufacturer Brainlab AG, Germania […]<\/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-10647","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\/10647","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=10647"}],"version-history":[{"count":4,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/posts\/10647\/revisions"}],"predecessor-version":[{"id":10744,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/posts\/10647\/revisions\/10744"}],"wp:attachment":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/media?parent=10647"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/categories?post=10647"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/tags?post=10647"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}