{"id":10636,"date":"2025-03-24T15:00:55","date_gmt":"2025-03-24T12:00:55","guid":{"rendered":"https:\/\/www.anm.ro\/en\/?page_id=10636"},"modified":"2025-08-04T09:53:13","modified_gmt":"2025-08-04T06:53:13","slug":"sumarul-notificarilor-in-materie-de-siguranta-in-teren-septembrie-2024","status":"publish","type":"post","link":"https:\/\/www.anm.ro\/en\/sumarul-notificarilor-in-materie-de-siguranta-in-teren-septembrie-2024\/","title":{"rendered":"Summary of field safety notifications \/ SEPTEMBER 2024"},"content":{"rendered":"

SUMMARY OF FIELD SAFETY NOTIFICATIONS \/ SEPTEMBER 2024<\/strong><\/p>\n

USER INFORMATION<\/strong>
\nTub de traheotomie din PVC siliconizat Portex \u2122 Blue Line \/ manufacturer Smiths Medical ASD Inc., SUA
\nRef. ANMDMR: 302.423c\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nDispozitiv de calibrare HbA1c II \/ manufacturer Randox Laboratories Ltd, Regatul Unit
\nRef. ANMDMR: 302.984\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nVideolaringoscop McGRATH\u2122 MAC \/ manufacturer Covidien LLC, SUA
\nRef. ANMDMR: 304.825c\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nHigh flow insufflation unit \/ manufacturer Olympus Medical Systems Corporation, Japonia
\nRef. ANMDMR: 305.390\/24<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nGeneral Hip Instruments \/ manufacturer Waldemar Link GmbH & Co. KG, Germania
\nRef. ANMDMR: 305.391\/24<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nCustom Tubing Set with Softline coating \/ manufacturer Maquet Cardiopulmonary GmbH, Germania
\nRef. ANMDMR: 305.392\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nBaterie corpuls cpr (LiPo) \/ manufacturer GS Elektromedizinische Ger\u00e4te G. Stemple GmbH, Germania
\nRef. ANMDMR: 305.415\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nFormaldehyde solution \/ manufacturer SAV Liquid Production GmbH, Germania
\nRef. ANMDMR: 305.430\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSoftware application: Enterprise Imaging XERO Viewer \/ manufacturer Agfa HealthCare NV, Belgia
\nRef. ANMDMR: 305.434\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nPatient data management system: M-PDMS \/ manufacturer Meierhofer Medizintechnik GmbH, Germania
\nRef. ANMDMR: 305.435\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nLoss of image data in DeepUnity DICOM Services \/ manufacturer DH Healthcare GmbH, Germania
\nRef. ANMDMR: 305.439\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nStolen ophthalmic medical devices: MR Q SLT model s\/ manufacturer Meridian Medical d.o.o., Slovenia
\nRef. ANMDMR: 305.475\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nOlympus SOLTIVE SuperPulsed Laser System \/ manufacturer Gyrus ACMI, Inc. (Olympus Surgical Technologies America), SUA
\nRef. ANMDMR: 305.651\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSoftware versions of X-ray TV system: SONIALVISION G4 \/ FLUOROspeed \/ manufacturer SHIMADZU Corporation, Japonia
\nRef. ANMDMR: 305.674\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nCryostat devices :Leica CM1950, Leica CM3050 S, Leica CM3050 S, Leica CM1850 UV, Leica CM1850 UV, Leica CM1850, Leica CM1510 S, Leica CM1100, Leica CM1500, Leica CM1800, Leica CM1900, Leica CM1900 UV, Leica CM3000, Leica CM3050 \/ manufacturer Leica Biosystems Nussloch GmbH, Germania
\nRef. ANMDMR: 305.676\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nMEERA-table controlled via an IR-Hand Control \/ manufacturer MAQUET GmbH, Germania
\nRef. ANMDMR: 305.691\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nOlympus EVIS EXERA\u2122 III GIF-H190N Gastrointestinal Videoscope, Olympus EVIS X1\u2122 GIF-1100
\nGastrointestinal Videoscope, Olympus EVIS X1 BF-H1100 and BF-1TH1100 Bronchovideoscopes, and Olympus EVIS EXERA III SIF-H190 Small Intestinal Videoscope\/ manufacturer Olympus Medical Systems Corporation, Japonia
\nRef. ANMDMR: 305.696\/24<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nBIOLOX\u00ae delta cup insert \u00d8 32\/44mm \/ manufacturer implantcast GmbH, Germania
\nRef. ANMDMR: 305.699\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nAlinity m HR HPV AMP Kit & Alinity m STI AMP Kit utilized with Alinity m System \/ manufacturer Abbott Molecular, Inc., SUA
\nRef. ANMDMR: 305.705\/24<\/p>\n

USER INFORMATION<\/strong>
\nOlympus OFP-2 Flushing Pump \/ manufacturer Olympus KeyMed, Marea Britanie
\nRef. ANMDMR: 305.731\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nVolumetric Pump: ARGUS 717V and ARGUS 718V \/ manufacturer CODAN ARGUS AG, Elve\u021bia
\nRef. ANMDMR: 305.734\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nShimadzu Digital Angiography System: Trinias (System with KS-100) \/ manufacturer SHIMADZU Corporation, Japonia
\nRef. ANMDMR: 305.785\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSistemele Philips Azurion \u0219i Allura Xper, Integris \u015fi MultiDiagnost Eleva\/ manufacturer Philips Medical Systems Nederland BV, Olanda
\nRef. ANMDMR: 305.792\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSIL-20ACXR CL, SIL-20ACHT CL, SIL-30AC CL \/ manufacturer SHIMADZU Corporation, Japonia
\nRef. ANMDMR: 305.794\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSIL-40C XR CL, SIL-40C X3 CL \/ manufacturer SHIMADZU Corporation, Japonia
\nRef. ANMDMR: 305.795\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nReusable Flow Sensor and Single Use Flow Sensor \/ produc\u0103tor SLE Ltd, Regatul Unit
\nRef. ANMDMR: 305.797\/24<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nSynthetic bone defect filler GUIDOR\u00ae easy-graft\u00ae CRYSTAL \/ manufacturer Degradable Solutions, Elve\u021bia
\nRef. ANMDMR: 305.799\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nActualizare librarie teste pentru analizoare de coagulare ACL Elite\/ Elite Pro \/ manufacturer Instrumentation Laboratory Co., SUA
\nRef. ANMDMR: 305.859\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nQualityMix Flowmeter \/ Quality Flowmeter \/ manufacturer DEHAS Medical Systems GmbH, Germania
\nRef. ANMDMR: 305.927\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSuport pentru pacient sistem RM \/ manufacturer Philips Medical Systems Nederland B.V., Olanda
\nRef. ANMDMR: 305.934\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nBlueflow Venous Stent \/ manufacturer Contract Medical International GmbH, Germania
\nRef. ANMDMR: 305.936\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSpaceplus Perfusor\u00ae with Take Over Mode (TOM) \/ manufacturer B.Braun Melsungen AG, Germania
\nRef. ANMDMR: 305.939\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSisteme cu ultrasunete ACUSON Maple si ACUSON Maple Select \/ manufacturer Siemens Medical Solutions USA, Inc. Ultrasound, SUA
\nRef. ANMDMR: 306.237\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSisteme cu ultrasunete ACUSON Redwood 1,0 \/ manufacturer Siemens Medical Solutions USA, Inc. Ultrasound, SUA
\nRef. ANMDMR: 306.240\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\n Sisteme cu ultrasunete ACUSON Juniper \u0219i ACUSON Juniper Select\/ manufacturer Siemens Medical Solutions USA, Inc. Ultrasound, SUA
\nRef. ANMDMR: 306.246\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSisteme cu ultrasunete ACUSON Redwood \/ manufacturer Siemens Medical Solutions USA, Inc. Ultrasound, SUA
\nRef. ANMDMR: 306.247\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSisteme cu ultrasunete ACUSON Juniper si ACUSON Maple \/ manufacturer Siemens Medical Solutions USA, Inc. Ultrasound, SUA
\nRef. ANMDMR: 306.248\/24<\/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 \/ SEPTEMBER 2024 USER INFORMATION Tub de traheotomie din PVC siliconizat Portex \u2122 Blue Line […]<\/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-10636","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\/10636","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=10636"}],"version-history":[{"count":4,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/posts\/10636\/revisions"}],"predecessor-version":[{"id":10654,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/posts\/10636\/revisions\/10654"}],"wp:attachment":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/media?parent=10636"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/categories?post=10636"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/tags?post=10636"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}