{"id":12220,"date":"2026-07-10T08:32:52","date_gmt":"2026-07-10T05:32:52","guid":{"rendered":"https:\/\/www.anm.ro\/en\/?p=12220"},"modified":"2026-07-10T08:35:38","modified_gmt":"2026-07-10T05:35:38","slug":"sumarul-notificarilor-in-materie-de-siguranta-in-teren-iunie-2026","status":"publish","type":"post","link":"https:\/\/www.anm.ro\/en\/sumarul-notificarilor-in-materie-de-siguranta-in-teren-iunie-2026\/","title":{"rendered":"Summary of field safety notifications \/ JUNE 2026"},"content":{"rendered":"

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

USER INFORMATION<\/strong>
\nDoppler cu Ultrasunete Maquet D900 furnizat \u00eempreun\u0103 cu Cardiosave Hybrid Intra-Aortic Balloon
\nPump (IABP) \/ manufacturer Datascope Corp., SUA
\nRef. ANMDMR: 117\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\n Dispozitivele Datascope Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP) \/ manufacturer Datascope Corporation, SUA
\nRef. ANMDMR: 132\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nPompe de contrapulsa\u021bie intraaortic\u0103 CS100 \u0219i CS300 \/ manufacturer Datascope Corp., SUA
\nRef. ANMDMR: 147\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nDatascope Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP) \/ manufacturer Datascope Corp., SUA
\nRef. ANMDMR: 296\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>\/
\nTest de diagnostic Biofire Ji Panel \/ manufacturer BioFire Diagnostics, LLC, SUA
\nRef. ANMDMR: 861\/26<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\n Solutie salin\u0103 Deltamedica \/ manufacturer Deltamedica GmbH, Germania
\nRef. ANMDMR: 1185\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nConnector pentru Monitoare fetale din gama Philips Avalon \/ manufacturer Philips Medizin Systeme B\u00f6blingen GmbH, Germania
\nRef. ANMDMR: 1187\/26<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nSisteme Relay Pro de gref\u0103 stent toracic, N4 \/ manufacturer Bolton Medical, Inc. (subsidiary of Terumo Medical, SUA
\nRef. ANMDMR: 1201\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nDispozitivul IntelliCuff \/ manufacturer Hamilton Medical AG, Elve\u021bia
\nRef. ANMDMR: 1208\/26<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nCanul\u0103 orofaringian\u0103 Guedel \/ manufacturer IntersurgicaL Ltd., Marea Britanie
\nRef. ANMDMR: 1215\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSet de transfer ChemoLock\u2122 \/ manufacturer ICU Medical Inc, SUA
\nRef. ANMDMR: 1217\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nMedumat Standard \/ manufacturer Weinmann Emergency Medical Technology GmbH, Germania
\nRef. ANMDMR: 1218\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\n Port acces AirSeal\u00ae \/ manufacturer Conmed Corporation, SUA
\nRef. ANMDMR: 1230\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nActualizarea Instruc\u021biunilor de utilizare pentru teaca deflectabil\u0103 FARADRIVETM \/ manufacturer Boston Scientific Corporation, SUA
\nRef. ANMDMR: 1247\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nCip senzor \/ manufacturer EKF-diagnostic GmbH, Germania
\nRef. ANMDMR: 1255\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nACS\u00ae Uni IM adapter \/ manufacturer implantcast GmbH, Germania
\nRef. ANMDMR: 1260\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nHigh Flow Insufflation Unit \/ manufacturer Olympus Medical Systems Corporation, Japonia
\nRef. ANMDMR: 1268\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nKit de analiz\u0103 a muta\u021biilor genei EGFR din ADN-ul tumoral circulant \/ manufacturer EntroGen Inc., SUA
\nRef. ANMDMR: 1274\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSistemele de anestezie Carestation 620\/650\/650c \u0219i 750\/750c \u2013 ventila\u021bia mecanic\u0103 nu este eficient\u0103 \u00een modul de ventila\u021bie cu control al volumului (VCV) \/ manufacturer Datex-Ohmeda, Inc., SUA
\nRef. ANMDMR: 1275\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSistem Integra\u00ae Omni-Tract\u00ae \/ manufacturer Integra Lifesciences Corporation, SUA
\nRef. ANMDMR: 1279\/26<\/span><\/a> <\/p>\n

USER INFORMATION<\/strong>
\nSta\u021bia central\u0103 Xhibit utilizat\u0103 cu un splitter DisplayPort
\nPierderea semnalului audio \u0219i\/sau video \/ manufacturer Spacelabs Healthcare Ltd, SUA
\nRef. ANMDMR: 1284\/26<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nAplicatori sferici pentru sistemul de radioterapie intraoperatorie Zeiss Intrabeam \/ manufacturer Carl Zeiss Meditec AG, Germania
\nRef. ANMDMR: 1287\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSenzor Dexcom G7 \/ manufacturer Dexcom Inc., SUA
\nRef. ANMDMR: 1306\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nDiagrama de orientare a implantului (IOD) Stella 2.0 \/ manufacturer STAAR Surgical AG, Elvetia
\nRef. ANMDMR: 1308\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nThe Angiographic C-arm Support \/ manufacturer Shimadzu Corporation, Japonia
\nRef. ANMDMR: 1310\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nLifecodes LSA Class II Kit \/ manufacturer Immucor GTI Diagnostics, Inc., SUA
\nRef. ANMDMR: 1320\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nAplica\u021bia Dexcom G6 \/ manufacturer Dexcom, Inc., SUA
\nRef. ANMDMR: 1322\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nVentilator Leoni 4 \/ manufacturer L\u00f6wenstein Medical SE & Co. KG, Germania
\nRef. ANMDMR: 1330\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nBlephademodex\/ manufacturer Laboratoires Th\u00e9a, Franta
\nRef. ANMDMR: 1332\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nCartu\u0219 de hemoperfuzie de unic\u0103 folosin\u021b\u0103 (seria HA) \/ manufacturer Jafron Biomedical Co., Ltd., China
\nRef. ANMDMR: 1335\/26<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nMOA-2 Biopsy forceps, single use, sterile, 1,6 x 800 mm \/ manufacturer Fehling Instruments GmbH, Germania
\nRef. ANMDMR: 1338\/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: 1339\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nVentilatoarele Astral 100 \u0219i Astral 150 \/ manufacturer Resmed Pty Ltd, Australia
\nRef. ANMDMR: 1343\/26<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nCanul\u0103 arterial\u0103 dintr-o singur\u0103 pies\u0103 alungit\u0103 EOPA\u2122 \/ manufacturer Medtronic, Inc, SUA
\nRef. ANMDMR: 1347\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nAparate de ventila\u021bie LEONI plus \/ 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>
\nSering\u0103 de control pentru angiografie cu adaptor rotative \/ manufacturer B. Braun Melsungen AG – Vascular Systems, Germania
\nRef. ANMDMR: 1353\/26<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nBurghiul de 3.4 mm pentru SwiveLock\u00ae \/ manufacturer Arthrex Inc, SUA
\nRef. ANMDMR: 1355\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nCapac distal pentru duodenoscop \/ manufacturer Olympus Medical Systems Corporation, Japonia
\nRef. ANMDMR: 1358\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nUmidificator cu bule \/ manufacturer Hsiner, Taiwan
\nRef. ANMDMR: 1359\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nCanul\u0103 de irigare \u0219i aspira\u021bie Wal \/ manufacturer Human Med AG, Germania
\nRef. ANMDMR: 1365\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSistem de perfuzie Medima \/ manufacturer Medima Sp. z o.o., Polonia
\nRef. ANMDMR: 1381\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nEtichet\u0103 incorect\u0103 pentru suportul de perete al sistemului Cardiohelp-i \/ manufacturer Maquet Cardiopulmonary GmbH, Germania
\nRef. ANMDMR: 1383\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nActualizare Instruc\u021biuni de utilizare pentru dispozitivul sleep safe harmony \/ manufacturer Fresenius Medical Care AG, Germania
\nRef. ANMDMR: 39684\/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 \/ JUNE 2026 USER INFORMATION Doppler cu Ultrasunete Maquet D900 furnizat \u00eempreun\u0103 cu Cardiosave Hybrid […]<\/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-12220","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\/12220","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=12220"}],"version-history":[{"count":0,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/posts\/12220\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/media?parent=12220"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/categories?post=12220"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/tags?post=12220"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}