{"id":12174,"date":"2026-06-15T10:01:44","date_gmt":"2026-06-15T07:01:44","guid":{"rendered":"https:\/\/www.anm.ro\/en\/?p=12174"},"modified":"2026-06-15T10:44:45","modified_gmt":"2026-06-15T07:44:45","slug":"sumarul-notificarilor-in-materie-de-siguranta-in-teren-mai-2026","status":"publish","type":"post","link":"https:\/\/www.anm.ro\/en\/sumarul-notificarilor-in-materie-de-siguranta-in-teren-mai-2026\/","title":{"rendered":"Summary of field safety notifications \/ MAY 2026"},"content":{"rendered":"

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

USER INFORMATION<\/strong>
\nSistemele Philips RM \/ manufacturer Philips Medical Systems Nederland B.V., Olanda
\nRef. ANMDMR: 419\/25<\/span><\/a><\/p>\n

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

USER INFORMATION<\/strong>
\nSistemele Philips RM \/ manufacturer Philips Medical Systems Nederland B.V., Olanda
\nRef. ANMDMR: 594\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nDepunere de aerosoli ob\u021binu\u021bi prin nebulizare pe senzorii de debit Trilogy Evo, Trilogy Evo O2, Trilogy EV300 \/ manufacturer Philips Respironics, Inc., SUA
\nRef. ANMDMR: 647\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nTest Thermo Fisher Scientific B\u00b7R\u00b7A\u00b7H\u00b7M\u00b7S PlGF Plus KRYPTOR \/ manufacturer B\u00b7R\u00b7A\u00b7HMS GmbH, Germania
\nRef. ANMDMR: 724\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nToate dispozitivele BiPAP A30, BiPAP A30 Hybrid, BiPAP A40 \u0219i BiPAP A40 Pro \/ manufacturer Respironics Inc., SUA
\nRef. ANMDMR: 845\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nNavify\u00ae Digital Pathology v2.5 \/ manufacturer Ventana Medical Systems Inc., SUA
\nRef. ANMDMR: 881\/26<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nCapete femurale ceramice LEC\u00aeplus \u0219i ELEC\u00aeplus Revision \/ manufacturer ARTIQO GmbH, Germania
\nRef. ANMDMR: 905\/26<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nCateter de ghidaj cu balon Bobby \/ manufacturer MicroVention, Inc., SUA
\nRef. ANMDMR: 910\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nAmplificator\/\u00eenregistrator EEG \/ manufacturer Micromed S.p.A, Italia
\nRef. ANMDMR: 927\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSoftware planificare implanturi \u0219i proiectare ghiduri chirurgicale exoplan \/ manufacturer exocad GmbH, Germania
\nRef. ANMDMR: 931\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nGETINGE 88-5 Washer Disinfector \/ manufacturer Getinge Disinfection AB, Suedia
\nRef. ANMDMR: 936\/25<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nMulti-Snare\u00ae \/ manufacturer pfm medical mepro gmbh, Germania
\nRef. ANMDMR: 966\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSX-ELLA Stent Danis (Stent Danis), Danis Procedure Pack \u2013 Basic,
\nDanis Procedure Pack \/ manufacturer ELLA-CS, s.r.o., Republica Ceh\u0103
\nRef. ANMDMR: 969\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSta\u021bii de anestezie Dr\u00e4ger Atlan \/ manufacturer Dr\u00e4gerwerk AG & Co. KGaA, Germania
\nRef. ANMDMR: 970\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nCGM CLINICAL \/ manufacturer CompuGroup Medical Software GmbH, Germania
\nRef. ANMDMR: 973\/26<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nCardiohelp II \/ manufacturer Maquet Cardiopulmonary GmbH, Germania
\nRef. ANMDMR: 975\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSistemul da Vinci\u00ae 5 \/ manufacturer Intuitive Surgical, Inc., SUA
\nRef. ANMDMR: 977\/26<\/span><\/a><\/p>\n

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

USER INFORMATION<\/strong>
\nSisteme Philips Allura \u0219i Azurion \/ manufacturer Philips Medical Systems Nederland BV, Tarile de Jos
\nRef. ANMDMR: 985\/26<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nSaw blade\/ manufacturer newbox medical GmbH, Germania
\nRef. ANMDMR: 990\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nAdaptor pentru pozi\u021bionarea capului\/ manufacturer Baxter Medical Systems GmbH + Co. KG, Germania
\nRef. ANMDMR: 991\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSistemele Philips Azurion \u0219i Allura\/ manufacturer Philips Medical Systems Nederland BV, \u021a\u0103rile de Jos
\nRef. ANMDMR: 993\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nZenition 10 \u0219i Zenition 30 \/ manufacturer Philips Medical Systems Nederland BV, \u021a\u0103rile de Jos
\nRef. ANMDMR: 994\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\n\u0218tift de fixare a fr\u00e2nei electrice de pe carul pacientului \/ manufacturer Intuitive Surgical, Inc., SUA
\nRef. ANMDMR: 1013\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSistemul de \u00cengrijire a Pacien\u021bilor (PCS) Merlin\u2122 3650 \/ manufacturer Abbott Medical, SUA
\nRef. ANMDMR: 1015\/26<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nStabilizator de \u021besuturi Octopus\u2122\/ manufacturer Medtronic, Inc., SUA
\nRef. ANMDMR: 1017\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSistem CASETM v7 \/ manufacturer GE Medical Systems Information Technologies, Inc.SUA
\nRef. ANMDMR: 1024\/26<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nRecall due to microbial contamination of MANUSHIELD CLEANER\/ manufacturer Dr. Schumacher GmbH, Germania
\nRef. ANMDMR: 1029\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSisteme Allia IGS \/ manufacturer GE Medical Systems SCS, Fran\u021ba
\nRef. ANMDMR: 1036\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nM\u0103nu\u0219i pentru examinare medicala \/ manufacturer Reflexx SPA, Italia
\nRef. ANMDMR: 1039\/26<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nProdusele ViaCath NG 4\/S\/5mm and ViaCath 20\/XL\/2-8-2mm \/ manufacturer VascoMed GmbH, Germania
\nRef. ANMDMR: 1053\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nOrbis Medication \/ manufacturer DH Healthcare GmbH, Germania
\nRef. ANMDMR: 1070\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nDefibrilator extern automatBeneHeart D1 \/ manufacturer Shenzhen Mindray Bio-Medical Electronics Co., Ltd., China
\nRef. ANMDMR: 1079\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nElectrocardiograf portabil \/ manufacturer Suzhou Beneware Medical Equipment Co., Ltd. China
\nRef. ANMDMR: 1085\/26<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\n\u0218urub canulat de compresie pentru osteosintez\u0103 5.0 headedCCS Long Thread 50\/20mm, 1\/Pkg (A-8216.50\/1) \/ manufacturer Medartis AG, Elevetia
\nRef. ANMDMR: 1086\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nActualizare firmware pentru panoul detectorului sistemului de imagistic\u0103 O2 O-arm\u2122 \/ manufacturer Medtronic Navigation, Inc., SUA
\nRef. ANMDMR: 1089\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nProdusul OncomineTM Dx Express Test Panel \/ manufacturer Life Technologies Corporation, SUA
\nRef. ANMDMR: 1092\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nCu\u021bit microchirurgical Sharpoint \/ manufacturer Surgical Specialties Mexico S. DE R.L. DE C.V., Mexic
\nRef. ANMDMR: 1094\/26<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nCanul\u0103 Priflex\u00ae \/ manufacturer Primed Halberstadt Medizintechnik GmbH, Germania
\nRef. ANMDMR: 1096\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nRobinete BD Connecta\u2122 \/ manufacturer BD Switzerland S\u00e0rl, Elvetia
\nRef. ANMDMR: 1100\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nDispozitivele Giraffe OmniBed \u0219i Giraffe OmniBed Carestation\/ manufacturer Datex-Ohmeda, Inc., SUA
\nRef. ANMDMR: 1101\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nServer de telemetrie ApexPro CARESCAPE v5.0 \u0219i v6.0 cu sta\u021bia central\u0103 CARESCAPE sau Centrul de informa\u021bii clinice CIC Pro \/ manufacturer GE Medical Systems Information Technologies, Inc., SUA
\nRef. ANMDMR: 1102\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nProdus AW Server 3.2 ext. 6.5\/ manufacturer GE Medical Systems SCS, SUA
\nRef. ANMDMR: 1103\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSistem ARTIS icono \/ manufacturer Siemens Healthcare GmbH, Germania
\nRef. ANMDMR: 1112\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSet de circuit respirator coaxial \/ manufacturer Hamilton Medical AG, Elvetia
\nRef. ANMDMR: 1113\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nCatetere de dilatare cu balon \/ manufacturer Boston Scientific Corporation, SUA
\nRef. ANMDMR: 1121\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nAPL valve\/ manufacturer Armstrong Medical Ltd, Marea Britanie
\nRef. ANMDMR: 1125\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSistem Philips Allura Xper, Allura CV20 \u0219i Allura Centron \/ manufacturer Philips Medical Systems Nederland BV, Tarile de Jos
\nRef. ANMDMR: 1131\/26<\/span><\/a><\/p>\n

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

PRODUCT RECALL<\/strong>
\nSistem de pozi\u021bionare cu cateter Harmony\u2122 \/ manufacturer Medtronic, Inc., SUA
\nRef. ANMDMR: 1142\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSistem automat de administrare a radiofarmaceuticelor IRIS \/ manufacturer Comecer Netherlands B.V., Tarile de Jos
\nRef. ANMDMR: 1145\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSistem radiologie interven\u021bional\u0103 \/ manufacturer Canon Inc., Japonia
\nRef. ANMDMR: 1158\/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 \/ MAY 2026 USER INFORMATION Sistemele Philips RM \/ manufacturer Philips Medical Systems Nederland B.V., […]<\/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-12174","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\/12174","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=12174"}],"version-history":[{"count":0,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/posts\/12174\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/media?parent=12174"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/categories?post=12174"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/tags?post=12174"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}