{"id":11759,"date":"2026-02-26T08:00:20","date_gmt":"2026-02-26T05:00:20","guid":{"rendered":"https:\/\/www.anm.ro\/en\/?p=11759"},"modified":"2026-02-26T09:37:58","modified_gmt":"2026-02-26T06:37:58","slug":"sumarul-notificarilor-in-materie-de-siguranta-in-teren-decembrie-2025","status":"publish","type":"post","link":"https:\/\/www.anm.ro\/en\/sumarul-notificarilor-in-materie-de-siguranta-in-teren-decembrie-2025\/","title":{"rendered":"Summary of field safety notifications \/ DECEMBER 2025"},"content":{"rendered":"

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

USER INFORMATION<\/strong>
\nSisteme Philips Allura \u0219i Azurion \/ manufacturer Philips Medical Systems Nederland BV., \u021a\u0103rile de Jos
\nRef. ANMDMR: 494\/25<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nMedihoney\u00ae Wound and Burn Products \/ manufacturer Derma Sciences, inc (in process in transitioning to Acell), Canada
\nRef. ANMDMR: 722\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nNIP and Rhinomanometry Components for the Vyntus Devices \/ manufacturer Jaeger Medical GmbH, Germania
\nRef. ANMDMR: 899\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nAnalizoare ABL800 Basic \u0219i ABL8XX Flex \/ manufacturer Radiometer Medical ApS, Danemarca
\nRef. ANMDMR: 1789\/25<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nSeturi HARTMANN care con\u021bin seringi de la manufacturerul MedNet \/ manufacturer PAUL HARTMANN AG, Germania
\nRef. ANMDMR: 1803\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nMixer gaze SLE1500 & Interflow \/ manufacturer SLE Limited, Marea Britanie
\nRef. ANMDMR: 1805\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nAplica\u021bia dispozitivului de programare pentru clinician Vanta\u2122 \u2013 \u00cencepere utilizare\/ manufacturer Medtronic, Inc., SUA
\nRef. ANMDMR: 1815\/25<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nNeurostimulator implantabil (INS) Vanta\u2122\/ manufacturer Medtronic Inc, SUA
\nRef. ANMDMR: 1819\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSistemele Philips Incisive CT \u0219i CT 5300 \/ manufacturer Philips Healthcare (Suzhou) Co., Ltd, China
\nRef. ANMDMR: 1823\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nTrocar Minop\u00ae \/ manufacturer Aesculap AG, Germania
\nRef. ANMDMR: 1832\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nPomp\u0103 de perfuzie BD neXus V700 \u0219i Pomp\u0103 de sering\u0103 BD neXus S700 \/ manufacturer Medcaptain Medical Technology Co., Ltd., China
\nRef. ANMDMR: 1835\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nbasixCOMPAK\u2122 \/ manufacturer Merit Medical Systems, Inc., SUA
\nRef. ANMDMR: 1836\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nMas\u0103 opera\u021bie Otesus \/ manufacturer MAQUET GmbH, Germania
\nRef. ANMDMR: 1858\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nAmbulatory Elastomeric Infusion Pumps \/ manufacturer Baxter Healthcare SA, Elevetia
\nRef. ANMDMR: 1863\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nTub de transfer LAF1000 \/ manufacturer Eckert & Ziegler BEBIG GmbH, Germania
\nRef. ANMDMR: 1865\/25<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nPALAMIX\u00ae uno \/ manufacturer Heraeus Medical GmbH, Germania
\nRef. ANMDMR: 1873\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nAnalytical Unit Cobas c 703 \/ manufacturer Roche Diagnostics GmbH, Germania
\nRef. ANMDMR: 1889\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nHDL colesterol direct \/ manufacturer Biosystems S.A., Spania
\nRef. ANMDMR: 1892\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nPachete de proceduri con\u021bin\u00e2nd seringi de la manufacturerul MedNet \/ manufacturer Lohmann & Rauscher International, Germania
\nRef. ANMDMR: 1901\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>\/
\n Pat Lisa LE \/ manufacturer FreiStil Tischlerei GmbH & Co. KG, Germania
\nRef. ANMDMR: 1902\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nAutomated Tube Sorter \/ manufacturer Sysmex Corporation Japan, Japonia
\nRef. ANMDMR: 1910\/25<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nMeliseptol foam pure spray cent \/ manufacturer B.Braun Medical AG, Elve\u021bia
\nRef. ANMDMR: 1916\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSistem de ghidare robotic\u0103 Mazor X\u2122 \/ manufacturer Mazor Robotics Ltd., Israel
\nRef. ANMDMR: 1919\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\n Analizoarele UniCel DxI 600 \u0219i 800 \/ manufacturer Beckman Coulter, Inc., SUA
\nRef. ANMDMR: 1923\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nLeksell GammaPlan\u00ae\/ manufacturer Elekta Solutions AB, Suedia
\nRef. ANMDMR: 1933\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSistemele Philips Azurion R3.0 \/ manufacturer Philips Medical Systems Nederland BV, Tarile de Jos
\nRef. ANMDMR: 1940\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nMonitor Tempus Pro \/ manufacturer Remote Diagnostic Technologies Ltd., Marea Britanie
\nRef. ANMDMR: 1941\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nCombur10 Test M u 411 Visual 100 Str \/ manufacturer Roche Diagnostics GmbH, Germania
\nRef. ANMDMR: 1946\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nDexcom One+ iOS CGM App version 1.2.0 \/ manufacturer Dexcom, Inc., SUA
\nRef. ANMDMR: 1952\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSisteme de anestezie Carestation seriile 600 \u0219i 700\/ manufacturer Datex-Ohmeda, Inc, SUA
\nRef. ANMDMR: 1953\/25<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nCodman Microsensor\u00ae Basic kit and Cerelink\u00ae ICP sensor Basic kit \/ manufacturer Integra LifeSciences Production Corporation, SUA
\nRef. ANMDMR: 1956\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nIsoSeed\u00ae \/ manufacturer Eckert & Ziegler Bebig GmbH, Germania
\nRef. ANMDMR: 1967\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nAlinity ci-series System Control Module (SCM) \/ manufacturer Abbott Laboratories, SUA
\nRef. ANMDMR: 1973\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nBiosynex S.pneumoniae \u0219i Biosynex S.pneumoniae BSX \/ manufacturer Biosynex SA, Fran\u021ba
\nRef. ANMDMR: 1983\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nPALACOS\u00ae and COPAL\u00ae pro systems \/ manufacturer Heraeus Medical GmbH, Germania
\nRef. ANMDMR: 1991\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nCleanCell M \/ manufacturer Roche Diagnostics GmbH, Germania
\nRef. ANMDMR: 1992\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nOrbis Medication \/ manufacturer DH Healthcare GmbH, Germania
\nRef. ANMDMR: 1998\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nGelsoft Plus, Gelweave, Thoraflex Hybrid \/ manufacturer Vascutek Ltd, Marea Britanie
\nRef. ANMDMR: 2002\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nMint Lesion\u2122 \/ manufacturer Mint Medical GmbH, Germania
\nRef. ANMDMR: 2003\/25<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nZimmer\u00ae Air Dermatome & Zimmer\u00ae Dermatome AN \/ manufacturer Zimmer Surgical, Inc., SUA
\nRef. ANMDMR: 2004\/25<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nStent de apozitie Lumen Axios\u2122 \/ manufacturer Boston Scientific Corporation, SUA
\nRef. ANMDMR: 2006\/25<\/span><\/a><\/p>\n

INFORMA\u021aIE PENT RU UTILIZATORI<\/strong>
\nSistem biopsie Brevera\u00ae\/ manufacturer Hologic, Inc., SUA
\nRef. ANMDMR: 2018\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nDxCare \/ manufacturer DH Healthcare GmbH, Germania
\nRef. ANMDMR: 2019\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSisteme Philips Azurion R3.1 \/ manufacturer Philips Medical Systems Nederland BV, Tarile de Jos
\nRef. ANMDMR: 2033\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSisteme Philips Azurion R2.1.10 \u0219i R2.2.10 \/ manufacturer Philips Medical Systems Nederland BV, Tarile de Jos
\nRef. ANMDMR: 2034\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nXN Series BB mode False low Residual WBC count \/ manufacturer Sysmex Corporation Japan, Japonia
\nRef. ANMDMR: 2037\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nTenos 4F \/ manufacturer Optimed medizinische Instrumente GmbH, Germania
\nRef. ANMDMR: 2049\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nBubble Sensor \/ manufacturer Maquet Cardiopulmonary GmbH, Germania
\nRef. ANMDMR: 2088\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nCampylobacter jejuni subsp. jejuni derivat din ATCC\u00ae 29428\u2122 \/ manufacturer Microbiologics, Inc., SUA
\nRef. ANMDMR: 2090\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nMaxima Diamond Burs \/ manufacturer Henry Schein Inc., SUA
\nRef. ANMDMR: 2099\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nCryoSure-DMSO \/ manufacturer WAK-Chemie Medical GmbH, Germania
\nRef. ANMDMR: 2100\/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 2025 USER INFORMATION Sisteme Philips Allura \u0219i Azurion \/ manufacturer Philips Medical Systems […]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-11759","post","type-post","status-publish","format-standard","hentry","category-uncategorized"],"post_mailing_queue_ids":[],"_links":{"self":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/posts\/11759","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=11759"}],"version-history":[{"count":1,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/posts\/11759\/revisions"}],"predecessor-version":[{"id":11762,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/posts\/11759\/revisions\/11762"}],"wp:attachment":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/media?parent=11759"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/categories?post=11759"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/tags?post=11759"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}