{"id":12265,"date":"2026-08-17T08:00:29","date_gmt":"2026-08-17T05:00:29","guid":{"rendered":"https:\/\/www.anm.ro\/en\/?p=12265"},"modified":"2026-08-17T15:45:35","modified_gmt":"2026-08-17T12:45:35","slug":"sumarul-notificarilor-in-materie-de-siguranta-in-teren-iulie-2026","status":"publish","type":"post","link":"https:\/\/www.anm.ro\/en\/sumarul-notificarilor-in-materie-de-siguranta-in-teren-iulie-2026\/","title":{"rendered":"Summary of field safety notifications \/ JULY 2026"},"content":{"rendered":"

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

PRODUCT RECALL<\/strong>
\nDispozitive medicale A.T.S.\u00ae 5000TS and A.T.S.\u00ae 3200TS Tourniquet Systems \/ manufacturer Zimmer Surgical, Inc., SUA
\nRef. ANMDMR: 92\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nLaringoscop video \/ manufacturer Remote Diagnostic Technologies Ltd., GB
\nRef. ANMDMR: 308\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nUn kit de analiz\u0103 a muta\u021biilor EGFR din ctDNA\/ manufacturer EntroGen Inc., SUA
\nRef. ANMDMR: 1274\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSistemul de dep\u0103rt\u0103toare chirurgicale Integra\u00ae Omni-Tract \/ manufacturer Integra Lifesciences Corporation, SUA
\nRef. ANMDMR: 1279\/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>
\nBD Connecta Stopcocks \/ manufacturer Lohmann & Rauscher International, Germania
\nRef. ANMDMR: 1387\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nDispozitive pentru anestezie Flow-i \/ manufacturer Maquet Critical Care AB, Suedia
\nRef. ANMDMR: 1399\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nDispozitive de programare Medtronic CareLink\u2122 2090 \u0219i CareLink\u2122 Encore 29901\/ manufacturer Medtronic Inc., SUA
\nRef. ANMDMR: 1400\/26<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nImplanturi pentru articula\u021bia temporomandibular\u0103 \/ manufacturer TMJ Solutions, LLC dba TMJ Concepts, SUA
\nRef. ANMDMR: 1416\/26<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nProduse pentru sutur\u0103 Surgipro\u2122, Surgipro II\u2122, Dermalon\u2122, V-Loc\u2122 90 \u0219i V-Loc\u2122 18029901 \/ manufacturer Covidien llc, SUA
\nRef. ANMDMR: 1433\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nMa\u0219ini de sp\u0103lat \u0219i dezinfectat automate (WD) +Soluscope Serie 4 \u0219i Serie 1 \/ manufacturer Soluscope SAS, Franta
\nRef. ANMDMR: 1434\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSilver Graft \/ manufacturer Aesculap AG, Germania
\nRef. ANMDMR: 1452\/26<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nDispozitiv pentru perfuzie \/ manufacturer BQ Plus Medical Co., Ltd., China
\nRef. ANMDMR: 1455\/26<\/span><\/a> <\/p>\n

PRODUCT RECALL<\/strong>
\nFibre laser chirurgicale \/ manufacturer KLS Martin SE & Co. KG, Germania
\nRef. ANMDMR: 1457\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSterilizaor Getinge Poladus 150 H1\/H2 \/ manufacturer MAQUET GmbH, Germania
\nRef. ANMDMR: 1469\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nVentilatoare din familia EVE \u0219i Oxylog 600 \/ manufacturer Fritz Stephan GmbH, Germania
\nRef. ANMDMR: 1473\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nCartu\u0219ul de senzori pentru Cobas b 123 \/ manufacturer Roche Diagnostics GmbH, Germania
\nRef. ANMDMR: 1474\/26<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nDispozitive OverStitch\u2122 Suture Cinch \u0219i Suture Cinch\u2013Long \/ manufacturer Boston Scientific Corporation, SUA
\nRef. ANMDMR: 1484\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSet de perfuzie de unic\u0103 folosin\u0163\u0103 BD\u00ae neXus \/ manufacturer Medcaptain Life Science Co., Ltd., China
\nRef. ANMDMR: 1487\/26<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nSet tuburi personalizate (CTPs) \/ manufacturer Maquet Cardiopulmonary GmbH, Germania
\nRef. ANMDMR: 1489\/26<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nCatetere uretrale Onli\u2122 \u0219i Infyna\u2122 \/ manufacturer Hollister Incorporated, SUA
\nRef. ANMDMR: 1491\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nAutomated Impella Controller (AIC) \/ manufacturer Abiomed Inc., SUA
\nRef. ANMDMR: 1505\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nDispozitiv medical pentru men\u021binerea temperaturii Heater Unit HU 35 \/ manufacturer Maquet Cardiopulmonary GmbH, Germania
\nRef. ANMDMR: 1509\/26<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nCateter venos lifecath CT PICC easy \/ manufacturer Vygon Germany GmbH, Germania
\nRef. ANMDMR: 1512\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nConcentrator de oxigen Kr\u00f6ber O2 \/ manufacturer Kr\u00f6ber Medizintechnik GmbH, Germania
\nRef. ANMDMR: 1520\/26<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nRampa de robineti Angiodyn Manifold 3 FRR 35BAR \/ manufacturer B. Braun Melsungen AG, Germania
\nRef. ANMDMR: 1529\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nImplanturi cardiace Figulla Flex II ASD Occluder \/ manufacturer Occlutech GmbH, Germania
\nRef. ANMDMR: 1536\/26<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nCateter cu balon OPN NC 400-015-004 \/ manufacturer SIS Medical AG, Elvetia
\nRef. ANMDMR: 1540\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nMonitor pentru pacien\u021bi \/ manufacturer Shenzhen Mindray Bio-Medical Electronics Co., Ltd., China
\nRef. ANMDMR: 1546\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSeturile de introducere Abiomed Impella 14 Fr \u0219i 23 Fr\/ manufacturer Oscor Inc., SUA
\nRef. ANMDMR: 1551\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSeturi de introducere Abiomed Impella 14 Fr \u0219i 23 Fr \/ manufacturer Oscor Inc., SUA
\nRef. ANMDMR: 1552\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nAnalizor de chimie clinic\u0103 DxC 500 AU \/ manufacturer Beckman Coulter Inc, SUA
\nRef. ANMDMR: 1561\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nAutomated Impella Controller (AIC) \/ manufacturer Abiomed Inc., SUA
\nRef. ANMDMR: 1564\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSet pentru administrare intravenoas\u0103 prin gravita\u021bie \/ manufacturer ICU Medical Inc, SUA
\nRef. ANMDMR: 1565\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSistem de management al medica\u021biei ORBIS Medication \/ manufacturer DH Healthcare GmbH, Germania
\nRef. ANMDMR: 1566\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nDispozitive cardiografie Cardiac Workstation 5000 \u0219i 7000 \/ manufacturer Philips Medizin Systeme B\u00f6blingen GmbH, Germania
\nRef. ANMDMR: 1574\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nFamilia de ventilatoare EVE \/ manufacturer Fritz Stephan GmbH, Germania
\nRef. ANMDMR: 1576\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nAnti-Spermatozoa Antibody (ASA) serum ELISA \/ manufacturer Demeditec Diagnostics GmbH, Germania
\nRef. ANMDMR: 1599\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSistem de management al medica\u021biei ORBIS Medication \/ manufacturer DH Healthcare GmbH, Germania
\nRef. ANMDMR: 1607\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSistem Munevo Drive \/ manufacturer Munevo GmbH, Germania
\nRef. ANMDMR: 1620\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\n Dispozitiv medical E-motion M25 product \/ manufacturer Alber GmbH, Germania
\nRef. ANMDMR: 1621\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\n Dispozitiv Spectralis\u00ae \/ manufacturer Heidelberg Engineering GmbH, Germania
\nRef. ANMDMR: 1625\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSisteme Philips Azurion R3.1 \/ manufacturer Philips Medical Systems Nederland BV, Tarile de Jos
\nRef. ANMDMR: 1628\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nArtis icono ceiling \/ manufacturer Siemens Healthcare GmbH, Germania
\nRef. ANMDMR: 1630\/26<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nTub Endotraheal Cu Balona\u0219 \/ manufacturer Zarys International sp. z o.o, Polonia
\nRef. ANMDMR: 1631\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nKit de inser\u021bie \/ manufacturer Maquet Cardiopulmonary GmbH, Germania
\nRef. ANMDMR: 1632\/26<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nSeturile Medline Soft Liner \/ manufacturer Medline Industries, LP, SUA
\nRef. ANMDMR: 1633\/26<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nSet perfuzie Beroset\u00ae \/ manufacturer Beromed GmbH Hospital Products, Geermania
\nRef. ANMDMR: 1655\/26<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nCatetere venoase centrale Certofix protect \/ manufacturer B Braun Melsungen AG, Germania
\nRef. ANMDMR: 1676\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nAnalizor Cobas \/ manufacturer Roche Diagnostics GmbH, Germania
\nRef. ANMDMR: 1683\/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

USER INFORMATION<\/strong>
\nVentilatoare neonatale medin-NC3 \/ manufacturer medin Medical Innovation GmbH, Germania
\nRef. ANMDMR: 1691\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSisteme Philips Azurion R3.1 \/ manufacturer Philips Medical Systems Nederland BV, Tarile de Jos
\nRef. ANMDMR: 2033\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSisteme Philips Azurion R2.1.10 \u0219i R2.2.10 \/ manufacturer Philips Medical Systems Nederland BV, Tarile de Jos
\nRef. ANMDMR: 2034\/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 \/ JULY 2026 PRODUCT RECALL Dispozitive medicale A.T.S.\u00ae 5000TS and A.T.S.\u00ae 3200TS Tourniquet Systems \/ […]<\/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-12265","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\/12265","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=12265"}],"version-history":[{"count":0,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/posts\/12265\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/media?parent=12265"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/categories?post=12265"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/tags?post=12265"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}