{"id":12116,"date":"2026-05-13T08:00:17","date_gmt":"2026-05-13T05:00:17","guid":{"rendered":"https:\/\/www.anm.ro\/en\/?p=12116"},"modified":"2026-05-27T14:10:48","modified_gmt":"2026-05-27T11:10:48","slug":"sumarul-notificarilor-in-materie-de-siguranta-in-teren-aprilie-2026","status":"publish","type":"post","link":"https:\/\/www.anm.ro\/en\/sumarul-notificarilor-in-materie-de-siguranta-in-teren-aprilie-2026\/","title":{"rendered":"Summary of field safety notifications \/ APRIL 2026"},"content":{"rendered":"

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

USER INFORMATION<\/strong>
\nRezultate posibil fals rezistente la antibiotice la cardurile VITEK\u00ae 2 AST GN pentru speciile Enterobacterales \u0219i\/sau Pseudomonas aeruginosa \/ manufacturer bioM\u00e9rieux, Inc., SUA
\nRef. ANMDMR: 127\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nLamp\u0103 chirurgical\u0103 Merivaara Qflow\/ manufacturer Merivaara Corporation, Finlanda
\nRef. ANMDMR: 216\/26<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nEyevisc\u2122 \/ manufacturer Biotech Visioncare Pvt. Ltd., India
\nRef. ANMDMR: 677\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nCateter Swan Ganz \/ manufacturer Edwards Lifesciences LLC, SUA
\nRef. ANMDMR: 679\/26<\/span><\/a><\/p>\n

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

USER INFORMATION<\/strong>
\nForceps \u0219i foarfece DEX \/ manufacturer Katalyst Surgical LLC, SUA
\nRef. ANMDMR: 730\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nNEXUS MEDIKATION\/ manufacturer NEXUS \/ CMC GmbH, Germania
\nRef. ANMDMR: 733\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nTuburi intrauterine \/ manufacturer Nucletron B.V., Tarile de Jos
\nRef. ANMDMR: 734\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nNeonatal heat therapy devices \/ manufacturer L\u00f6wenstein Medical SE & Co. KG, Germania
\nRef. ANMDMR: 736\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nVue Motion V12 \/ manufacturer Philips Medical Systems Nederland B.V., \u0162\u0103rile de Jos
\nRef. ANMDMR: 740\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nHF Cable, Bipolar \/ manufacturer Olympus Winter & Ibe GmbH, Germania
\nRef. ANMDMR: 758\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nipsogen kit\/ manufacturer QIAGEN GmbH, Germania
\nRef. ANMDMR: 759\/26<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nCatetere cu balon de crioabla\u021bie POLARx\u2122 \u0219i POLARx\u2122 Fit, teci ghidabile POLARSHEATH\u2122 \/ manufacturer Boston Scientific Corporation, SUA
\nRef. ANMDMR: 765\/26<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nSisteme de stenturiE-vita OPEN NEO , E-tegra ,E-nside TAAA Multibranch \/ manufacturer JOTEC GmbH, Germania
\nRef. ANMDMR: 768\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSTHEMO ANTI Xa M \/ manufacturer Diagnostica Stago, Franta
\nRef. ANMDMR: 770\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nModul Flex Infusion (Perfuzie flexibil\u0103) al SynchroMed\u2122 \/ manufacturer Medtronic, Inc., SUA
\nRef. ANMDMR: 772\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nRuperea \u0219uruburilor suportului de canul\u0103 de la sistemele da Vinci X, Xi \/ manufacturer Intuitive Surgical, Inc., SUA
\nRef. ANMDMR: 774\/26<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nSuruburi AR-8933L-16 \/ manufacturer Arthrex INC, SUA
\nRef. ANMDMR: 780\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nNon-Tamperproof Battery Door \/ manufacturer Advanced Bionics LLC, SUA
\nRef. ANMDMR: 783\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSering\u0103 de control angiografic Namic cu adaptor rotativ (RA) (seringi Namic RA) \/ manufacturer Medline Industries, LP, SUA
\nRef. ANMDMR: 786\/26<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nDispozitiv chirurgical Thunderbeat\u2122 II \/ manufacturer Gyrus ACMI, Inc. (Olympus Surgical Technologies America), SUA
\nRef. ANMDMR: 797\/26<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nMerit 16F Dual-Valved Splittable Sheath Introducer \/ manufacturer Arrow International LLC (Subsidiary of Teleflex Incorporated), SUA
\nRef. ANMDMR: 799\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nEdwards EVOQUE Tricuspid Valve Replacement System \/ manufacturer Edwards Lifesciences LLC, SUA
\nRef. ANMDMR: 813\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nAvantgarde 4 and Zenit \/ manufacturer Otto Bock Mobility Solutions GmbH, Germania
\nRef. ANMDMR: 839\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nGamma-GT Reagent \/ manufacturer VitalScientific, SUA
\nRef. ANMDMR: 842\/26<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nInZone Detachment System\/ manufacturer Stryker Neurovascular, SUA
\nRef. ANMDMR: 846\/26<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nSperm Concentration Rapid Test Kit and Bowel Health Rapid Test Kit\/ manufacturer Hangzhou Alltest Biotech Co.,Ltd., China
\nRef. ANMDMR: 850\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nOrbis Medication \/ manufacturer DH Healthcare GmbH, Germania
\nRef. ANMDMR: 851\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSistemele Philips Azurion \/ manufacturer Philips Medical Systems Nederland B.V., Tarile de Jos
\nRef. ANMDMR: 852\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nCryo.s with External Thread \/ manufacturer Greiner Bio-One GmbH, Germania
\nRef. ANMDMR: 863\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSistem de analiz\u0103 a s\u00e2ngelui Epoc\u00ae \/ manufacturer Epocal Inc., Canada
\nRef. ANMDMR: 866\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nAmpliCube Respiratory Viral Panel 5 with ampliCube Respiratory Viral Panel 1 \/ manufacturer Mikrogen GmbH, Germania
\nRef. ANMDMR: 870\/26<\/span><\/a><\/p>\n

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

PRODUCT RECALL<\/strong>
\nAural Vent Tubes (PTFE) \/ manufacturer Exmoor Plastics Limited, Marea Britanie
\nRef. ANMDMR: 885\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nCO2 Laser Systems and VersaPulse PowerSuite (VPPS) Dual Wavelength (DW) \/ manufacturer Lumenis Ltd, Israel
\nRef. ANMDMR: 886\/26<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nHuber Needles Polyperf \/ manufacturer Perouse Medical, Franta
\nRef. ANMDMR: 887\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nVivo 45 LS \/ manufacturer Breas Medical AB, Suedia
\nRef. ANMDMR: 890\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nTRAb human 1 step RIA \/ manufacturer Medipan GmbH, Germania
\nRef. ANMDMR: 893\/26<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nELEC\u00aeplus Ceramic Femoral Head andELEC\u00aeplus Revision Ceramic Femoral Head \/ manufacturer Artiqo GmbH, Germania
\nRef. ANMDMR: 905\/26<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nMedistrip- Vein Stripper \/ manufacturer Neuromedex GmbH, Germania
\nRef. ANMDMR: 908\/26<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nBobby\u2122 Balloon Guide Catheter \/ manufacturer MicroVention, Inc., SUA
\nRef. ANMDMR: 910\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nPalamix\u00ae uno \u0219i Palamix\u00ae duo \/ manufacturer Heraeus Medical GmbH, Germania
\nRef. ANMDMR: 917\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSering\u0103 de control pentru angiografie cu adaptor rotativ (RA) \u00een pachet procedural Kimal \/ manufacturer Kimal PLC, Marea Britanie
\nRef. ANMDMR: 919\/26<\/span><\/a><\/p>\n

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

USER INFORMATION<\/strong>
\nImpella Purge Cassette \/ manufacturer Abiomed Inc., SUA
\nRef. ANMDMR: 934\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nDexcom G7 \/ manufacturer Dexcom, Inc., SUA
\nRef. ANMDMR: 935\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSingle Use Ligating Device \/ manufacturer Olympus Medical Systems Corporation, Japonia
\nRef. ANMDMR: 1626\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nHemosIL SynthAsyl\/ manufacturer Instrumentation Laboratory Co., SUA
\nRef. ANMDMR: 3324\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nGEM PAKs\/ manufacturer Instrumentation Laboratory Co., SUA
\nRef. ANMDMR: 17986\/26 <\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nCalibratori de Heparin\u0103 HemosIL\/ manufacturer Instrumentation Laboratory Co., SUA
\nRef. ANMDMR: 24170\/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 \/ APRIL 2026 USER INFORMATION Rezultate posibil fals rezistente la antibiotice la cardurile VITEK\u00ae 2 […]<\/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-12116","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\/12116","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=12116"}],"version-history":[{"count":0,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/posts\/12116\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/media?parent=12116"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/categories?post=12116"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/tags?post=12116"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}