{"id":12027,"date":"2026-04-03T08:00:46","date_gmt":"2026-04-03T05:00:46","guid":{"rendered":"https:\/\/www.anm.ro\/en\/?p=12027"},"modified":"2026-04-03T11:58:04","modified_gmt":"2026-04-03T08:58:04","slug":"sumarul-notificarilor-in-materie-de-siguranta-in-teren-februarie-2026","status":"publish","type":"post","link":"https:\/\/www.anm.ro\/en\/sumarul-notificarilor-in-materie-de-siguranta-in-teren-februarie-2026\/","title":{"rendered":"Summary of field safety notifications \/ FEBRUARY 2026"},"content":{"rendered":"

SUMMARY OF FIELD SAFETY NOTIFICATIONS \/ FEBRUARY 2026<\/strong><\/p>\n

USER INFORMATION<\/strong>
\nCobas pro\/pure Non-monotonous Spline calibration \/ manufacturer Hitachi High-Technologies Corporation, Japonia
\nRef. ANMDMR: 95\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nTread \/ manufacturer h\/p\/cosmos sports & medical gmbh, Germania
\nRef. ANMDMR: 231\/26<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nOrsiro Sirolimus Eluting Coronary Stent System\/ manufacturer Biotronik AG (a Teleflex company), Elve\u021bia
\nRef. ANMDMR: 233\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSistemele Philips Azurion \/ manufacturer Philips Medical Systems Nederland BV., Tarile de Jos
\nRef. ANMDMR: 237\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nDisposable Infusion Set \/ manufacturer Medcaptain Life Science Co., Ltd., China
\nRef. ANMDMR: 238\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nAnalizoarele automate de biochimie Beckman Coulter DxC 700 AU \u0219i AU5800 \/ manufacturer Beckman Coulter, Inc., SUA
\nRef. ANMDMR: 269\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSistem RMN Vantage Galan 3T \/ manufacturer Canon Medical Systems Corporation, Japonia
\nRef. ANMDMR: 291\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nPompe BD Alaris\u2122 neXus \u0219i Alaris\u2122 Plus \/ manufacturer BD Switzerland S\u00e0rl, Elvetia
\nRef. ANMDMR: 325\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSpace\u00aeplus Perfusor\u00ae \/ manufacturer B.Braun Melsungen AG, Germania
\nRef. ANMDMR: 331\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nPens\u0103 Maryland bipolar\u0103 \u0219i pens\u0103 de prindere fenestrat\u0103 bipolar\u0103 \/ manufacturer Covidien llc, SUA
\nRef. ANMDMR: 339\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nMonitoarele Qube Compact \u0219i Xprezzon \/ manufacturer Spacelabs Healthcare, SUA
\nRef. ANMDMR: 346\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSistemele cu pompe de insulin\u0103 seriile MiniMed\u2122 Paradigm\u2122, MiniMed\u2122 600 \u0219i MiniMed\u2122 700 \/ manufacturer Medtronic Minimed, SUA
\nRef. ANMDMR: 369\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nEchipamentele Leksell Gamma Knife\u00ae Perfexion\u2122, Leksell Gamma Knife\u00ae ICON\u2122, Leksell Gamma Knife\u00ae Elekta Esprit\u2122 \/ manufacturer Elekta Solutions AB, Suedia
\nRef. ANMDMR: 374\/26<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nDispozitiv Clarity II ICD \/ manufacturer Lutronic Corporation, Coreea de Sud
\nRef. ANMDMR: 378\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nTriLock Screw \/ manufacturer Medartis AG, Elvetia
\nRef. ANMDMR: 401\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nAnalizoare ABL90 Flex Plus \/ manufacturer Radiometer Medical ApS, Danemarca
\nRef. ANMDMR: 421\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nRocket Seldinger Chest Drain Kit \/ manufacturer Rocket Medical Plc, Marea Britanie
\nRef. ANMDMR: 423\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nCapillary Tube Kit \/ manufacturer Medica Corporation, SUA
\nRef. ANMDMR: 428\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSingle Use Biopsy Valve \/ manufacturer Olympus Medical Systems Corporation, Japonia
\nRef. ANMDMR: 433\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nOrbis Anesthesia \/ manufacturer DH Healthcare GmbH, Germania
\nRef. ANMDMR: 437\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nORBIS Medication \/ manufacturer DH Healthcare GmbH, Germania
\nRef. ANMDMR: 465\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nCorpuls1 \/ manufacturer GS Elektromedizinische Ger\u00e4te G. Stemple GmbH, Germania
\nRef. ANMDMR: 466\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSistem Haptic\u00ae PIP\/ manufacturer implantcast GmbH, Germania
\nRef. ANMDMR: 470\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\n Software DeepUnity PACSonWEB \/ manufacturer DH Healthcare GmbH, Germania
\nRef. ANMDMR: 473\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nDigital Angiography System Trinias \/ manufacturer SHIMADZU Corporation, Japonia
\nRef. ANMDMR: 474\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nDxCare Prescriptions Multimodales \/ manufacturer DH Healthcare GmbH, Germania
\nRef. ANMDMR: 475\/26<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\n21 Gauge Winged Infusion Set \/ manufacturer Mentor, SUA
\nRef. ANMDMR: 483\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSistemele da Vinci X \u0219i da Vinci Xi \/ manufacturer Intuitive Surgical, Inc., SUA
\nRef. ANMDMR: 484\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSistemele da Vinci X \u0219i da Vinci Xi \/ manufacturer Intuitive Surgical Inc., SUA
\nRef. ANMDMR: 485\/26<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nInstinct Plus Endoscopic Clipping Device \/ manufacturer Cook Endoscopy\/Wilson Cook Medical, Inc., SUA
\nRef. ANMDMR: 487\/26<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nEndo-Model M \/ manufacturer Waldemar Link GmbH & Co.KG, Germania
\nRef. ANMDMR: 495\/26<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nPaediatric arterial cannula and Flex Line Venous Catheter \/ manufacturer Andocor NV, Belgia
\nRef. ANMDMR: 496\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nComvita\u2122 Medihoney\u00ae Wound Gel \/ manufacturer Derma Sciences, Inc (in process in transitioning to Acell), Canada
\nRef. ANMDMR: 722\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nVentilator BiPAP A40 Pro \/ manufacturer Philips Respironics, Inc, SUA
\nRef. ANMDMR: 1402\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nRecuperarea neurostimulatorului implantabil (INS) Vanta\u2122 \/ manufacturer Medtronic Inc., SUA
\nRef. ANMDMR: 1819\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nProdusele Microbiologics KWIK-STIK\u2122 \u0219i LYFO DISK\u2122 \/ manufacturer Microbiologics, Inc., SUA
\nRef. ANMDMR: 2090\/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 2026 USER INFORMATION Cobas pro\/pure Non-monotonous Spline calibration \/ manufacturer Hitachi High-Technologies Corporation, […]<\/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-12027","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\/12027","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=12027"}],"version-history":[{"count":1,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/posts\/12027\/revisions"}],"predecessor-version":[{"id":12030,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/posts\/12027\/revisions\/12030"}],"wp:attachment":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/media?parent=12027"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/categories?post=12027"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/tags?post=12027"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}