{"id":12351,"date":"2026-10-12T12:01:18","date_gmt":"2026-10-12T09:01:18","guid":{"rendered":"https:\/\/www.anm.ro\/en\/?p=12351"},"modified":"2026-10-12T12:06:42","modified_gmt":"2026-10-12T09:06:42","slug":"sumarul-notificarilor-in-materie-de-siguranta-in-teren-septembrie-2026","status":"publish","type":"post","link":"https:\/\/www.anm.ro\/en\/sumarul-notificarilor-in-materie-de-siguranta-in-teren-septembrie-2026\/","title":{"rendered":"Summary of field safety notifications \/ SEPTEMBER 2026"},"content":{"rendered":"

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

USER INFORMATION<\/strong>
\nVentilator de terapie intensiv\u0103 elisa \/ manufacturer L\u00f6wenstein Medical Innovation GmbH & Co. KG, Germania
\nRef. ANMDMR: 1141\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nVentilator neonatal LEONI plus HFO \/LEONI plus transport \/ manufacturer L\u00f6wenstein Medical SE & Co. KG, Germania
\nRef. ANMDMR: 1351\/26<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nDefec\u021biuni ale cablului de prehensor la instrumentele reutilizabile
\ncu f\u0103lci Vinci X, da Vinci Xi \u0219i dV5\/ manufacturer Intuitive Surgical, Inc., SUA
\nRef. ANMDMR: 1484\/26<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nAdaptor urologic Ialuadapter\u00ae \/ UroDapter \u00ae\/ manufacturer Pharmico Medical Kft, Ungaria
\nRef. ANMDMR: 1688\/26<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nGynecare TVT Exact\u00ae \/ manufacturer Ethicon SARL, Elve\u021bia
\nRef. ANMDMR: 1703\/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>
\nMasa electric\u0103 HE Spectralis \/ manufacturer CX Engineering sp. z o.o., Polonia
\nRef. ANMDMR: 1944\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSisteme RM \/ manufacturer Philips Medical Systems Nederland B.V., \u021a\u0103rile de Jos
\nRef. ANMDMR: 1945\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\n Kit detectare anticorpi Anti-Anexina V IgG \/ manufacturer ORGENTEC Diagnostika GmbH, Germania
\nRef. ANMDMR: 1949\/26<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nOlympus Hemostasis Devices \/ manufacturer Gyrus ACMI, Inc. (Olympus Surgical Technologies America), SUA
\nRef. ANMDMR: 1955\/26<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nSfere pasive Northern Digital Inc (NDI) \u0219i truse cu ace de biopsie Medtronic \/ manufacturer Northern Digital Inc., SUA
\nRef. ANMDMR: 1960\/26<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nDefibrilator extern HeartSine\u00ae samaritan\u00ae PAD \/ manufacturer HeartSine Technologies, LTD, Marea Britanie
\nRef. ANMDMR:1971\/26<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nDefibrilator extern HeartSine\u00ae samaritan\u00ae PAD \/ manufacturer HeartSine Technologies, LTD, SUA
\nRef. ANMDMR: 1972\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nElectrocardiograf SE-1201 Pro \/ manufacturer Edan Instruments, Inc., China
\nRef. ANMDMR: 1973\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nMonitoare pentru pacien\u021bi Philips IntelliVue \/ manufacturer Philips Medizin Systeme B\u00f6blingen GmbH, Germania
\nRef. ANMDMR: 1977\/26<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nSfincter urinar artificial Victo \/ manufacturer Promedon S.A., Argentina
\nRef. ANMDMR: 1978\/26<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nSet de reactivi HumaMeter A1c Reagent Kit \/ manufacturer Human Gesellschaft f\u00fcr Biochemica und Diagnostica mbH, Germania
\nRef. ANMDMR: 1979\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nPanel diagnostic molecular BIOFIRE Pneumonia Panel plus, BIOFIRE Joint Infection Panel \/ manufacturer BioFire Diagnostics LLC, SUA
\nRef. ANMDMR: 1991\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSistem Centricity Enterprise \/ Centricity PACS\/ Workflow Core Services \/ manufacturer GE Healthcare, SUA
\nRef. ANMDMR: 1992\/26<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nCanul\u0103 BlueLavage\u00ae LongBoneTip \/ manufacturer UTK Solution GmbH, Germania
\nRef. ANMDMR: 2016\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSoftware imagistic\u0103 medical\u0103 Fluosoft LX \/ manufacturer Fluoptics SAS, Fran\u021ba
\nRef. ANMDMR: 2017\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nPlatform\u0103 software Applied Biosystems\u2122 Diomni\u2122 Software \/ manufacturer Life Technologies Holdings Pte Ltd., Singapore
\nRef. ANMDMR: 2020\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nDispozitiv de ocluzie a apendicelui atrial st\u00e2ng Amplatzer\u2122 Amulet\u2122 \/ manufacturer Abbott Medical, SUA
\nRef. ANMDMR: 2028\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSisteme de imagistic\u0103 prin rezonan\u021b\u0103 magnetic\u0103 (RM) cu imagistic\u0103 prin tensori de difuzie (DTI) \/ manufacturer Philips Medical Systems Nederland B.V., \u021a\u0103rile de Jos
\nRef. ANMDMR: 2037\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nAnalizor de chimie clinic\u0103 DxC 500 AU \/ manufacturer Beckman Coulter, Inc., SUA
\nRef. ANMDMR: 2041\/26<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nProduse cu fibr\u0103 laser SOLTIVE\u2122 \/ manufacturer Olympus Gyrus ACMI, Inc., SUA
\nRef. ANMDMR: 2042\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nCatetere neurochirurgicale Neurovent \u0219i Neurodur \/ manufacturer Raumedic AG, Germania
\nRef. ANMDMR: 2050\/26<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nMicrocatetere Direxion\u2122 \u0219i Direxion HI-FLO\u2122 \/ manufacturer Boston Scientific Corporation, SUA
\nRef. ANMDMR: 2052\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSistem IntelliSpace Critical Care and Anesthesia (ICCA) \/ manufacturer Philips Medizin Systeme B\u00f6blingen GmbH, Germania
\nRef. ANMDMR: 2059\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSpectral CT \/ manufacturer Philips Medical Systems Nederland B.V., \u021a\u0103rile de Jos
\nRef. ANMDMR: 2063\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nCatetere VACS II\/III \/ manufacturer Osypka GmbH, Germania
\nRef. ANMDMR: 2066\/26<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nSistem Oculus Biom\u00ae 6 \/ manufacturer Oculus Optikger\u00e4te GmbH, Germania
\nRef. ANMDMR: 2067\/26<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nDr\u00e4ger VentStar Resus Neo \u0219i VentStar Resuscitaire \/ manufacturer Dr\u00e4gerwerk AG & Co. KGaA, Germania
\nRef. ANMDMR: 2068\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nNadal\u00ae Rota-Adenovirus Test\/ manufacturer nal von minden GmbH, Germania
\nRef. ANMDMR: 2074\/26<\/span><\/a> <\/p>\n

USER INFORMATION<\/strong>
\nTub de traheostomie Tracoe Vario P \u0219i setul Tracoe Experc Vario \/ manufacturer Tracoe Medical GmbH, Germania
\nRef. ANMDMR: 2075\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nEndoscop cu ultrasunete \/ manufacturer Pentax Medical Corporation, Germania
\nRef. ANMDMR: 2089\/26<\/span><\/a> <\/p>\n

USER INFORMATION<\/strong>
\nEroare de cuplu excesiv \u00een sistemul de chirurgie asistat\u0103 robotic Hugo\u2122 (RAS) \/ manufacturer Covidien llc, SUA
\nRef. ANMDMR: 2095\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nDexcom G7 iOS App version 2.12 \/ manufacturer Dexcom, Inc., SUA
\nRef. ANMDMR: 2119\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nCobas c 303 Analytical Unit \/ manufacturer Roche Diagnostics GmbH, Germania
\nRef. ANMDMR: 2122\/26<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nBronwel Night \/ manufacturer H\u00e4lsa Pharma GmbH, Germania
\nRef. ANMDMR: 2123\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nLi-Ion Rechargeable Battery \/ manufacturer GS Elektromedizinische Ger\u00e4te G. Stemple GmbH, Germania
\nRef. ANMDMR: 2129\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nAIC Purge Flag Failures \/ manufacturer Abiomed Inc., SUA
\nRef. ANMDMR: 2130\/26<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nCitraLock Syringe 4% \/ manufacturer Sterisets Manufacturing S.A., Portugalia
\nRef. ANMDMR: 2138\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nDispozitive tip manager de dispozitiv CareLink\u2122 SmartSync\u2122 (SmartSync) \/ manufacturer Medtronic, Inc., SUA
\nRef. ANMDMR: 2151\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nRecomandare privind actualizarea software-ului iPadOS pentru a reduce frecven\u021ba deconect\u0103rilor Bluetooth de la CareLink\u2122 SmartSync\u2122 \/ manufacturer Medtronic, Inc., SUA
\nRef. ANMDMR: 2152\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nAplica\u021bie Dexcom G7 iOS App \/ G7 Watch iOS App \/ G7 Android App \/ manufacturer Dexcom, Inc., SUA
\nRef. ANMDMR: 2161\/26<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nSingle Use Ligating Device Polyloop \/ manufacturer Olympus Medical Systems Corporation, Japonia
\nRef. ANMDMR: 2163\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSistem de diagnosticare cu ultrasunete Philips Lumify \/ manufacturer Philips Ultrasound LLC., SUA
\nRef. ANMDMR: 2190\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nPrecision Pointer Electro Magnetic (EM) \/ manufacturer Stryker Leibinger GmbH & Co. KG, Germania
\nRef. ANMDMR: 2207\/26<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nStryker InterPulse System \/ manufacturer Stryker Instruments USA, SUA
\nRef. ANMDMR: 2218\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nPaediatric care bed \/ manufacturer KayserBetten GmbH & Co. KG, Germania
\nRef. ANMDMR: 2221\/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 \/ SEPTEMBER 2026 USER INFORMATION Ventilator de terapie intensiv\u0103 elisa \/ manufacturer L\u00f6wenstein Medical Innovation […]<\/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-12351","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\/12351","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=12351"}],"version-history":[{"count":1,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/posts\/12351\/revisions"}],"predecessor-version":[{"id":12354,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/posts\/12351\/revisions\/12354"}],"wp:attachment":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/media?parent=12351"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/categories?post=12351"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/tags?post=12351"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}