{"id":11477,"date":"2025-12-23T08:12:07","date_gmt":"2025-12-23T05:12:07","guid":{"rendered":"https:\/\/www.anm.ro\/en\/?p=11477"},"modified":"2025-12-23T08:19:17","modified_gmt":"2025-12-23T05:19:17","slug":"sumarul-notificarilor-in-materie-de-siguranta-in-teren-noiembrie-2025","status":"publish","type":"post","link":"https:\/\/www.anm.ro\/en\/sumarul-notificarilor-in-materie-de-siguranta-in-teren-noiembrie-2025\/","title":{"rendered":"Summary of field safety notifications \/ NOVEMBER 2025"},"content":{"rendered":"

SUMMARY OF FIELD SAFETY NOTIFICATIONS \/ NOVEMBER 2025<\/strong><\/p>\n

USER INFORMATION<\/strong>
\nComponenta Q-link 13\/ manufacturer Liko AB, Suedia
\nRef. ANMDMR: 551\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nElectrolyte Analyzer \/ manufacturer Roche Diagnostics GmbH, Germania
\nRef. ANMDMR: 1519\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nBicarbonat \/ manufacturer Beckman Coulter Ireland Inc., Irlanda
\nRef. ANMDMR: 1556\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nAutomated Impella Controller \/ manufacturer Abiomed Inc., SUA
\nRef. ANMDMR: 1572\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSalte pneumatice terapeutice Accella \/ manufacturer Hillrom S.A.S., Fran\u021ba
\nRef. ANMDMR: 1573\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nKit BD BACTEC\u2122 MGIT 960 PZA\u2122 \/ manufacturer Becton Dickinson and Company, SUA
\nRef. ANMDMR: 1574\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSistemele Philips CT \/ manufacturer Philips Healthcare (Suzhou) Co., Ltd, China
\nRef. ANMDMR: 1577\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\n Easy Pulse \/ manufacturer SCHILLER AG, Elve\u0163ia
\nRef. ANMDMR: 1582\/25<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nInjekt\u00ae Luer Solo \/ manufacturer B.Braun Melsungen AG, Germania
\nRef. ANMDMR: 1583\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nCardiosave Intra-Aortic Balloon Pumps \/ manufacturer Datascope Corp., SUA
\nRef. ANMDMR: 1585\/25<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nExtremiLock Ankle 7 Hole Right Anterolateral Tibia Plate \/ manufacturer OSTEOMED, LLC, SUA
\nRef. ANMDMR: 1590\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nIsoSeed \/ manufacturer Eckert & Ziegler BEBIG GmbH, Germania
\nRef. ANMDMR: 1592\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\n Sisteme Zenition 10 \u0219i Zenition 30\/ manufacturer Philips Medical Systems Nederland BV, T\u0103rile de Jos
\nRef. ANMDMR: 1602\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nAccelerator liniar digital \/ manufacturer Elekta Solutions AB, Suedia
\nRef. ANMDMR: 1606\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nAcului rotativ ZenFlex \/ manufacturer Kerr Italia S.r.l., Italia
\nRef. ANMDMR: 1611\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nDr\u00e4ger Catheter Mounts ErgoStar CM 40, ErgoStar CM 45, ErgoStar CM 55, ErgoStar CM 60 \/ manufacturer Dr\u00e4gerwerk AG & Co. KGaA, Germania
\nRef. ANMDMR: 1620\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nAmnioquick Card Amnioquick Duo+ \/ manufacturer Biosynex SA, Fran\u0163a
\nRef. ANMDMR: 1628\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nHand Files \/ manufacturer Kerr Italia S.r.l., Italia
\nRef. ANMDMR: 1631\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nColour Coded Syringes \/ manufacturer MedNet GmbH, Germania
\nRef. ANMDMR: 1634\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nCGM CLINICAL Medication \/ manufacturer CompuGroup Medical Software GmbH, Germania
\nRef. ANMDMR: 1646\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nVapor 2000 \u0219i Vapor 3000 \/ manufacturer Dr\u00e4gerwerk AG & Co. KGaA, Germania
\nRef. ANMDMR: 1655\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nOrbis Medication \/ manufacturer DH Healthcare GmbH, Germania
\nRef. ANMDMR: 1658\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nBaterii \/ manufacturer Klaxon Mobility GmbH, Austria
\nRef. ANMDMR: 1671\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nAlinity ci-series System Control Module (SCM) \/ manufacturer Abbott Laboratories, SUA
\nRef. ANMDMR: 1685\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nMonitor de presiune intracranian\u0103 Pressio\u00ae2 \/ manufacturer SOPHYSA, Fran\u0163a
\nRef. ANMDMR: 1687\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nElecsys Anti-TSHR assay \/ manufacturer Roche Diagnostics GmbH, Germania
\nRef. ANMDMR: 1705\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nCompoflow systems \/ manufacturer Fresenius Kabi AG, Germania
\nRef. ANMDMR: 1737\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSunStim, SunStim Plus, SunStim Pro \/ manufacturer EasyMed Instruments Co., Ltd, China
\nRef. ANMDMR: 1755\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSingle use ligating device polyloop\/ manufacturer Olympus Medical Systems Corporation, Germania
\nRef. ANMDMR: 1759\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nMonitoare pacien\u021bi Carescape B450, Carescape One \/ manufacturer GE Medical Systems Information Technologies, Inc., SUA
\nRef. ANMDMR: 1761\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nEcografie ViewPointTM \/ manufacturer GE Healthcare GmbH, Germania
\nRef. ANMDMR: 1775\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nGBM Ab \/ manufacturer Demeditec Diagnostics GmbH, Germania
\nRef. ANMDMR: 1782\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nAnti-GBM \/ manufacturer ORGENTEC Diagnostika GmbH, Germania
\nRef. ANMDMR: 1783\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nAnalizoare din seria ABL800 \/ manufacturer Radiometer Medical ApS, Danemarca
\nRef. ANMDMR: 1789\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nVaporizator electronic V90 pentru utilizare cu sistemul de anestezie A9 \/ manufacturer Shenzhen Mindray Bio-Medical Electronics Co., Ltd., China
\nRef. ANMDMR: 1791\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nI-Mag Screen reagent\/ manufacturer Diagast, Fran\u021ba
\nRef. ANMDMR: 1880\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSistemele cu ultrasunete cu baterii Flex Focus, bkSpecto, bk3000, bk3500, bk5000 \u0219i bkActiv \/ manufacturer BK Medical Aps, Danemarca
\nRef. ANMDMR: 1881\/25<\/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 \/ NOVEMBER 2025 USER INFORMATION Componenta Q-link 13\/ manufacturer Liko AB, Suedia Ref. ANMDMR: 551\/25 […]<\/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-11477","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\/11477","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=11477"}],"version-history":[{"count":1,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/posts\/11477\/revisions"}],"predecessor-version":[{"id":11479,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/posts\/11477\/revisions\/11479"}],"wp:attachment":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/media?parent=11477"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/categories?post=11477"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/tags?post=11477"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}