{"id":12279,"date":"2026-09-01T08:00:43","date_gmt":"2026-09-01T05:00:43","guid":{"rendered":"https:\/\/www.anm.ro\/en\/?p=12279"},"modified":"2026-09-01T13:11:31","modified_gmt":"2026-09-01T10:11:31","slug":"sumarul-notificarilor-in-materie-de-siguranta-in-teren-august-2026","status":"publish","type":"post","link":"https:\/\/www.anm.ro\/en\/sumarul-notificarilor-in-materie-de-siguranta-in-teren-august-2026\/","title":{"rendered":"Summary of field safety notifications \/ AUGUST 2026"},"content":{"rendered":"

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

PRODUCT RECALL<\/strong>
\nVentilatoare Newport\u2122 HT70 \u0219i Newport\u2122 HT70 Plus\/ manufacturer Covidien llc, SUA
\nRef. ANMDMR: 450\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSta\u021bie de anestezie Atlan \/ manufacturer Dr\u00e4gerwerk AG & Co. KGaA, Germania
\nRef. ANMDMR: 970\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong><\/strong>
\nPhilips Azurion Systems \/ manufacturer Philips Medical Systems Nederland BV, \u021a\u0103rile de Jos
\nRef. ANMDMR: 983\/26<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nSet de circuit respirator coaxial \/ manufacturer Hamilton Medical AG, Elve\u021bia
\nRef. ANMDMR: 1206\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nGenefill DX \/ manufacturer BioScience GmbH, Germania
\nRef. ANMDMR: 1637\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nDispozitiv Hemospray Endoscopic Hemostat \/ manufacturer Cook Endoscopy\/Wilson Cook Medical, Inc., SUA
\nRef. ANMDMR: 1667\/26<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nAdaptor urologic steril Ialudapter \/ Urodapter \/ manufacturer Pharmico Medical Kft, Ungaria
\nRef. ANMDMR: 1688\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nVentilatoare meonatale \/ manufacturer medin Medical Innovation GmbH, Germania
\nRef. ANMDMR: 1691\/26<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nImplant dentar Roxolid\u00ae \/ manufacturer Institut Straumann AG, Elve\u021bia
\nRef. ANMDMR: 1695\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nAnti-Spermatozoa Antibody (ASA) serum ELISA \/ manufacturer Demeditec Diagnostics GmbH, Germania
\nRef. ANMDMR: 1697\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nCentrifug\u0103 Rotofix 32A \/ manufacturer Andreas Hettich GmbH, Germania
\nRef. ANMDMR: 1700\/26<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nSistem Gynecare TVT Exact\u00ae \/ manufacturer Ethicon SARL, Elve\u021bia
\nRef. ANMDMR: 1703\/26<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nGref\u0103 vascular\u0103 Cardioroot Woven grafts \/ manufacturer Intervascular SAS, Franta
\nRef. ANMDMR: 1721\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nAnalizor de biochimie Beckman Coulter AU480 \/ manufacturer Beckman Coulter, Inc., SUA
\nRef. ANMDMR: 1724\/26<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nTij\u0103 femural\u0103 EcoFit\u00ae \/ manufacturer implantcast GmbH, Germania
\nRef. ANMDMR: 1730\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nCitometru flux CyFlow\u2122 Counter \/ manufacturer Sysmex Partec GmbH, Germania
\nRef. ANMDMR: 1741\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nFore Sight Oximeter cable \/ manufacturer Chirag Shah, SUA
\nRef. ANMDMR: 1758\/26<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nSistem Stryke Flow PS and AHTO Tube Set Leaking \/ manufacturer Stryker Endoscopy, SUA
\nRef. ANMDMR: 1769\/26<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nSmartbag \/ manufacturer Fresenius Medical Care AG, Germania
\nRef. ANMDMR: 1774\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nDiverse dispositive\/manufacturer Shimadzu Corporation, Japonia
\nRef. ANMDMR: 1778\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nCup\u0103 acetabular\u0103 VarioCup \/ manufacturer aap Joints GmbH, Germania
\nRef. ANMDMR: 1802\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSema \/ manufacturer Schiller AG, Elve\u021bia
\nRef. ANMDMR: 1803\/26<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nBravo\u2122 CF capsule delivery device \/ manufacturer Given Imaging, Inc., SUA
\nRef. ANMDMR: 1805\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\n Sistem Philips Patient Information Center iX \/ manufacturer Philips Medizin Systeme B\u00f6blingen GmbH, Germania
\nRef. ANMDMR: 1806\/26<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nOlympus Hemostasis Device \/ manufacturer Gyrus ACMI, Inc. (Olympus Surgical Technologies America), SUA
\nRef. ANMDMR: 1810\/26<\/span><\/a> <\/p>\n

USER INFORMATION<\/strong>
\nSistem DermaV \/ manufacturer Cynosure Lutronic Technology Corporation, Coreea de Sud
\nRef. ANMDMR: 1815\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nProblem\u0103 software EPIQ Elite v14.0 cu traductorul C5-1 \/ manufacturer Philips Medical Systems Nederland B.V., \u021a\u0103rile de Jos
\nRef. ANMDMR: 1826\/26<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nImlant ortopedic \/ manufacturer Howmedica Osteonics Corp., SUA
\nRef. ANMDMR: 1833\/26<\/span><\/a> <\/p>\n

USER INFORMATION<\/strong>
\nThermo Fisher Scientific MAS\u00ae Omni\u2022IMMUNE PRO Liquid Assayed Integrated Immunoassay Control \/ manufacturer Microgenics Corporation, as part of Thermo Fisher Scientific, SUA
\nRef. ANMDMR: 1842\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSoftware radioterapie VERIQA RT MonteCarlo 3D \/ manufacturer PTW Freiburg, Germania
\nRef. ANMDMR: 1845\/26<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nSistem Impella CP\u00ae cu SmartAssist\u00ae\/ manufacturer Abiomed Inc., SUA
\nRef. ANMDMR: 1853\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nAdeziv siliconic Vygon \/ manufacturer Vygon Germany GmbH, Germania
\nRef. ANMDMR: 1854\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nORBIS Medication \/ manufacturer DH Healthcare GmbH, SUA
\nRef. ANMDMR: 1855\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\n Sistem ORBIS Medication \/ manufacturer DH Healthcare GmbH, SUA
\nRef. ANMDMR: 1856\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nAnalizoarele din seria iQ200 \u0219i analizoarele Iris DxU 840m\/850m \/ manufacturer Beckman Coulter Ireland Inc., Irlanda
\nRef. ANMDMR: 1859\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\n Nexus \/ Medikation \/ manufacturer Nexus \/ CMC GmbH, Germania
\nRef. ANMDMR: 1861\/26<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nCatetere angiografice ImagerTM II \/ manufacturer Boston Scientific Corporation., SUA
\nRef. ANMDMR: 1862\/26<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\n Conectori ANRYV \/ manufacturer Balt Extrusion SAS, Franta
\nRef. ANMDMR: 1867\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nPanou BD Phoenix\u2122 CPO Detect cu 6 godeuri \/ manufacturer Becton, Dickinson and Company, SUA
\n Ref. ANMDMR: 1881\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nPalacos\u00ae and Copal\u00ae pro systems \/ manufacturer Heraeus Medical GmbH, Germania
\nRef. ANMDMR: 1886\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nTrocar cu balon structural Covidien Auto Suture\u2122 \u0219i trocar cu v\u00e2rf bont Covidien Auto Suture\u2122 \/ manufacturer Covidien IIc, SUA
\nRef. ANMDMR: 1907\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nVentStar Resus Neo \u015fi VentStar Resuscitaire \/ manufacturer Dr\u00e4gerwerk AG & Co. KGaA, Germania
\nRef. ANMDMR: 1911\/26<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nTub de traheostomie Shiley\u2122 Hi-Lo Evac cu man\u0219on \/ manufacturer Covidien llc, SUA
\nRef. ANMDMR: 1912\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nTub de traheostomie Shiley\u2122 Hi-Lo Evac cu man\u0219on\/ manufacturer GE Medical Systems Information Technologies, Inc., SUA
\nRef. ANMDMR: 1913\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nLi-Ion Rechargeable Battery \/ manufacturer GS Elektromedizinische Ger\u00e4te G. Stemple GmbH, Germania
\nRef. ANMDMR: 1915\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nNova StatStrip\u00ae(Gen 2) Glucose and Glucose\/\u03b2-Ketone Hospital Meter Systems \/ manufacturer Nova Biomedical Cooporation, SUA
\nRef. ANMDMR: 1916\/26<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nTrilogy Delivery Catheter \/ manufacturer JenaValve Technology Inc, SUA
\nRef. ANMDMR: 1917\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nDispozitiv Olympus POWERSEAL \/ manufacturer Gyrus ACMI, Inc. (Olympus Surgical Technologies America), SUA
\nRef. ANMDMR: 1925\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nORBIS Medication \/ manufacturer DH Healthcare GmbH, Germania
\nRef. ANMDMR: 1928\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSistem DeepUnity PACSonWEB \/ manufacturer DH Healthcare GmbH, Germania
\nRef. ANMDMR: 1930\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSistem Centricity High Acuity Anesthesia \/ Critical Care \/ manufacturer GE Healthcare Finland Oy, Finlanda
\nRef. ANMDMR: 1933\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nTest QIAstat-Dx\u00ae Gastrointestinal Panel 2 \/ manufacturer QIAGEN GmbH, Germania
\nRef. ANMDMR: 1934\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nDisposable Needle Guide \/manufacturer Wellgo Medical Products Gmbh, Germania
\nRef. ANMDMR: 1939\/26<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nEYEFILL\u2122 C Cohesive Ophthalmic Viscoelastic Devices (OVDs)\/ manufacturer Bausch & Lomb Incorporated, SUA
\nRef. ANMDMR: 1940\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSistem FDR Visionary Suite\/ manufacturer Shimadzu Corporation, Japonia
\nRef. ANMDMR: 1941\/26<\/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 \/ AUGUST 2026 PRODUCT RECALL Ventilatoare Newport\u2122 HT70 \u0219i Newport\u2122 HT70 Plus\/ manufacturer Covidien llc, […]<\/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-12279","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\/12279","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=12279"}],"version-history":[{"count":1,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/posts\/12279\/revisions"}],"predecessor-version":[{"id":12281,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/posts\/12279\/revisions\/12281"}],"wp:attachment":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/media?parent=12279"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/categories?post=12279"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/tags?post=12279"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}