{"id":10644,"date":"2025-03-24T15:05:34","date_gmt":"2025-03-24T12:05:34","guid":{"rendered":"https:\/\/www.anm.ro\/en\/?page_id=10644"},"modified":"2025-08-04T09:04:13","modified_gmt":"2025-08-04T06:04:13","slug":"sumarul-notificarilor-in-materie-de-siguranta-in-teren-ianuarie-2025","status":"publish","type":"post","link":"https:\/\/www.anm.ro\/en\/sumarul-notificarilor-in-materie-de-siguranta-in-teren-ianuarie-2025\/","title":{"rendered":"Summary of field safety notifications \/ JANUARY 2025"},"content":{"rendered":"

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

USER INFORMATION<\/strong>
\nCompatibilitate seringa heparin\u0103 \/ manufacturer Fresenius Medical Care AG, Germania
\nRef. ANMDMR: 2226\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nCGM CLINICAL Medication \/ manufacturer CompuGroup Medical Software GmbH
\nRef. ANMDMR: 6092\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nIntermediate ceiling construction \/ manufacturer KLS Martin SE & Co. KG, Germania
\nRef. ANMDMR: 6094\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nFigulla Flex II ASD \/ manufacturer Occlutech GmbH, Germania
\nRef. ANMDMR: 6105\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nHemosIL Liquid Anti-Xa\/ manufacturer Instrumentation Laboratory Co., SUA
\nRef. ANMDMR: 6296\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nmint Lesion\u2122 \/ manufacturer Mint Medical GmbH, Germania
\nRef. ANMDMR: 6802<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nVNS Therapy\u2122 Generators – Model 1000 SenTiva\u2122 si 1000-D SenTiva Duo\u2122 \/ manufacturer LivaNova USA, Inc., USA
\nRef. ANMDMR: 7074\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nInfinity\u00ae CentralStation \/ manufacturer Draeger Medical System, Inc., SUA
\nRef. ANMDMR: 8151\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nDeepUnity Viewer 2.x \/ manufacturer DH Healthcare GmbH, Germania
\nRef. ANMDMR: 8156\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\niGFBP-1 Rapid Test Cassette (Vaginal Secretion) \/ manufacturer Hangzhou Alltest Biotech Co.,Ltd., China
\nRef. ANMDMR: 8158\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nVideoprocesorul PENTAX MEDICAL EPK-i8020c \u0219i videoendoscoapele PENTAX Medical din seria i20c \/ manufacturer HOYA Corp., Japonia
\nRef. ANMDMR: 8160\/25<\/p>\n

USER INFORMATION<\/strong>
\nOptipac\u00ae Vacuum mixing system \/ manufacturer Biomet France, Franta
\nRef. ANMDMR: 8163\/25<\/p>\n

USER INFORMATION<\/strong>
\nHeparin syringe compatibility with 4008H, 4008B, 4008S \/ manufacturer Fresenius Medical Care AG, Germania
\nRef. ANMDMR: 9306\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nRaised toilet seats: SmartFix and TSE 2.0 \/ manufacturer DIETZ GmbH, Germania
\nRef. ANMDMR: 9308\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSurgical soft-tissue manipulation forceps \/ manufacturer Aesculap AG, Germania
\nRef. ANMDMR: 9311\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nDevice sterilization\/disinfection container \/ manufacturer Aesculap AG, Germania
\nRef. ANMDMR: 9315\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nElectrosurgical Electrode \/ manufacturer Dongguan QueenMed Equipment Mfg Co Ltd,China
\nRef. ANMDMR: 9319\/25<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nPotential contamination with process-related foreign particles \/ manufacturer HMT Medizintechnik GmbH, Germania
\nRef. ANMDMR: 9322\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\n3M\u2122 Transbond\u2122 Self-Etching Primer \/ manufacturer 3M Unitek Corporation, SUA
\nRef. ANMDMR: 9330\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nToric Intraocular Lenses \/ manufacturer Carl Zeiss Meditec AG, Germania
\nRef. ANMDMR: 9336\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nActualizare software pentru ventilatorul de terapie intensiv\u0103 elisa 300\/500\/600\/800\/800VIT \/ manufacturer L\u00f6wenstein Medical Innovation GmbH & Co. KG, Germania
\nRef. ANMDMR:11055\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nBeneFusion nSP (Configured PCA ) \/ manufacturer Shenzhen Mindray Scientific Co., Ltd., China
\nRef. ANMDMR: 11240\/25<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nLumenis Pulse 120H Holmium Laser Systems \/ manufacturer Lumenis Ltd., Israel
\nRef. ANMDMR: 12077\/25<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nDispozitivul de embolizare Pipeline\u2122 Vantage cu Shield Technology\u2122 \/ manufacturer Micro Therapeutics, Inc, SUA
\nRef. ANMDMR: 12153\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nCorrosion of the Ice Bracket inside the water tank \/ manufacturer Maquet Cardiopulmonary GmbH, Germania
\nRef. ANMDMR: 12931\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nXhibit Telemetry Receiver \/ manufacturer Spacelabs Healthcare Inc, USA
\nRef. ANMDMR: 12935\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSedaconda Syringe \/ manufacturer Sedana Medical Ltd, Irlanda
\nRef. ANMDMR: 12948\/25<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nCatheters- lifecath PICC pur \/ manufacturer Vygon GmbH & Co. KG, Germania
\nRef. ANMDMR: 12975\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSistemele Philips Allura and Azurion \/ manufacturer Philips Medical Systems Nederland BV, Olanda
\nRef. ANMDMR: 12978\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSistemele Philips Allura \u015fi Azurion \/ manufacturer Philips Medical Systems Nederland BV, Olanda
\nRef. ANMDMR: 13001\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSistemele cu pompe de insulin\u0103 MiniMed\u2122 Paradigm\u2122, MiniMed\u2122 Seria 600 \u0219i MiniMed\u2122 din seria 700 \/ manufacturer Medtronic Minimed, SUA
\nRef. ANMDMR: 13061\/25<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nPulsar-35 Self -expanding Nitrinol Stent System \/ manufacturer Biotronik AG, Elve\u021bia
\nRef. ANMDMR: 13063\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nCRP IP Reagent \/ manufacturer VitalScientific, Franta
\nRef. ANMDMR: 13239\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nBone screw \/ manufacturer Medartis AG, Elve\u021bia
\nRef. ANMDMR: 13261\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nDeepUnity Viewer 2.x \/ manufacturer DH Healthcare GmbH, Germania
\nRef. ANMDMR: 13275\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nMedima Infusion Pump \/ manufacturer Medima Sp. z o. o., Polonia
\nRef. ANMDMR: 13278\/25<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nThermo Scientific\u2122 Yersinia Selective Agar \/ manufacturer Oxoid Deutschland GmbH, Germania
\nRef. ANMDMR: 13280\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nDefec\u021biuni ale cablurilor de \u00eenclinare la pensa Tenaculum \u0219i instrumentul Small GraptorTM de la da Vinci X \u0219i Xi \/ manufacturer Intuitive Surgical, Inc., USA
\nRef. ANMDMR: 13284\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nDefec\u021biuni ale cablului de prehensor pe instrumentele reutilizabile da Vinci X \u0219i Xi cu f\u0103lci \/ manufacturer Intuitive Surgical, Inc., SUA
\nRef. ANMDMR: 13287\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nImplantable Ventricular Circulatory Assist System \/ manufacturer HeartWare Inc., SUA
\nRef. ANMDMR: 13357\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nORBIS Medication 3.x \/ manufacturer DH Healthcare GmbH, Germania
\nRef. ANMDMR: 13381\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nORBIS Medication 3.x \/ manufacturer DH Healthcare GmbH, Germania
\nRef. ANMDMR: 13382\/25<\/p>\n

USER INFORMATION<\/strong>
\nCartu\u0219 BD PCR \/ manufacturer Becton, Dickinson and Company, SUA
\nRef. ANMDMR: 307.757\/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 \/ JANUARY 2025 USER INFORMATION Compatibilitate seringa heparin\u0103 \/ manufacturer Fresenius Medical Care AG, Germania […]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-10644","post","type-post","status-publish","format-standard","hentry"],"post_mailing_queue_ids":[],"_links":{"self":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/posts\/10644","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=10644"}],"version-history":[{"count":3,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/posts\/10644\/revisions"}],"predecessor-version":[{"id":10658,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/posts\/10644\/revisions\/10658"}],"wp:attachment":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/media?parent=10644"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/categories?post=10644"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/tags?post=10644"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}