{"id":11228,"date":"2025-09-19T13:00:39","date_gmt":"2025-09-19T10:00:39","guid":{"rendered":"https:\/\/www.anm.ro\/en\/?p=11228"},"modified":"2025-09-19T10:58:51","modified_gmt":"2025-09-19T07:58:51","slug":"sumarul-notificarilor-in-materie-de-siguranta-in-teren-august-2025","status":"publish","type":"post","link":"https:\/\/www.anm.ro\/en\/sumarul-notificarilor-in-materie-de-siguranta-in-teren-august-2025\/","title":{"rendered":"Summary of field safety notifications \/ AUGUST 2025"},"content":{"rendered":"

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

PRODUCT RECALL<\/strong>
\nDenti Dental Implant System \/ manufacturer DenTi System KFT, Ungaria
\nRef. ANMDMR: 687\/25<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nMagic-Soft \/ manufacturer REBOTEC Rehabilitationsmittel GmbH, Germania
\nRef. ANMDMR: 690\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nPrisMax Systems si TherMax Blood Warmer Units \/ manufacturer Baxter Healthcare SA, Elve\u021bia
\nRef. ANMDMR: 716\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nKit de diagnosticare in vitro (IVDR) ChimerisMonitor IVD \/ manufacturer BIOTYPE GmbH, Germania
\nRef. ANMDMR: 717\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nVITROS Chemistry Products LAC Slides \/ manufacturer QuidelOrtho (Ortho Clinical Diagnostics Inc), SUA
\nRef. ANMDMR: 719\/25<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nDispozitiv de umflare EncoreTM 26, Kit EncoreTM 26 Advantage, Kit NephroMaxTM, Kit UroMaxUltraTM\/ manufacturer Boston Scientific Corporation, SUA
\nRef. ANMDMR: 720\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nmedin-NC3 \/ manufacturer medin Medical Innovations GmbH, Germania
\nRef. ANMDMR: 721\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nMedihoney\u00ae Wound and Burn Products \/ manufacturer Derma Sciences, Inc, Canada
\nRef. ANMDMR: 722\/25<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nColor Cuff\u00ae Sterile Disposable Tourniquet Cuffs \/ manufacturer Stryker Instruments a division of Stryker Corporation, SUA
\nRef. ANMDMR: 724\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nTracoe Vario Tube\/ manufacturer Tracoe Medical GmbH, Germania
\nRef. ANMDMR: 725\/25<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nViziShot 2 FLEX (19G) \/ manufacturer Gyrus ACMI, Inc. (Olympus Surgical Technologies America), SUA
\nRef. ANMDMR: 726\/25<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nAlcon Standalone Vitrectomy Consumables \/ manufacturer Alcon Laboratories, Inc., SUA
\nRef. ANMDMR: 727\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nVersius Surgeon Console \/ manufacturer CMR Surgical Ltd, Marea Britanie
\nRef. ANMDMR: 728\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nPhilips Azurion \u0219i Allura cu op\u021biune UPS monofazat\u0103\/ manufacturer Philips Medical Systems Nederland BV, \u021a\u0103rile de Jos
\nRef. ANMDMR: 729\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSisteme Allura Xper \/manufacturer Philips Medical Systems Nederland BV, \u021a\u0103rile de Jos
\nRef. ANMDMR: 730\/25<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nReduced irrigation flow in two BSD 515 irrigation handpieces \/ manufacturer B\u00fcrki inno med AG, Elve\u021bia
\nRef. ANMDMR: 731\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nN-LINEpro \/ manufacturer MEDlight GmbH, Herford, Germania
\nRef. ANMDMR: 733\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSKULL TRACTION TONG LARGE\/ manufacturer Aesculap AG, Germania
\nRef. ANMDMR: 736\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nImplant SIGNUS PSL052043 \/ manufacturer SIGNUS Medizintechnik GmbH, Germania
\nRef. ANMDMR: 775\/25<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nElectrod de ad\u00e2ncime MICRODEEP\u00ae \/ manufacturer DIXI Medical S.A.S., Franta
\nRef. ANMDMR: 776\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nTentos 4F\/ manufacturer optimed Medizinsiche, Germania
\nRef. ANMDMR: 832\/25<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nCateterul de evacuare pentru cordul st\u00e2ng DLP\u2122 nu \u00ee\u0219i p\u0103streaz\u0103 forma \/ manufacturer Medtronic Inc., SUA
\nRef. ANMDMR: 835\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nAnalizoare de hematologie UniCel DxH Coulter configurate cu
\nfotometru LED HGB \/manufacturer Beckman Coulter, Inc., SUA
\nRef. ANMDMR: 836\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nVentilatoare din seria SOPHIE 2020 \/manufacturer Fritz Stephan GmbH, Germania
\nRef. ANMDMR: 837\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nHistoCore PELORIS 3\/manufacturer Leica Biosystems Melbourne Pty Ltd, Australia
\nRef. ANMDMR: 838\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSpeedControl Dial component utilized with the SmartDrive MX2+ Power Assist Device \/ manufacturer Max Mobility LLC, SUA
\nRef. ANMDMR: 839\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nBeneVision N1 \/ manufacturer Shenzhen Mindray Bio-Medical Electronics Co., Ltd., China
\nRef. ANMDMR: 858\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nInspection of Magnet Venting System \/ manufacturer Siemens Healthcare GmbH, Germania
\nRef. ANMDMR: 860\/25<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nEndo-Model -M Modular Knee Prosthesis System \/ manufacturer Waldemar Link GmbH & Co. KG, Germania
\nRef. ANMDMR: 861\/25<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nBlueflow Venous Stent\/ manufacturer Contract Medical International GmbH(dba Heraeus Medevio), Germania
\nRef. ANMDMR: 896\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nEvo IQ Large Volumetric Pumps (LVP) \/ manufacturer Baxter Healthcare SA, Elve\u021bia
\nRef. ANMDMR: 897\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSistem RMN Siemens Magnetom Flow.Neo \/ manufacturer Siemens Healthcare GmbH, Germania
\nRef. ANMDMR: 898\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nVyntus products with SNIP\/RHINO Option \/ manufacturer Jaeger Medical GmbH, Germania
\nRef. ANMDMR: 899\/25<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nELAN 4 Fixed Duraguard\/ manufacturer Aesculap AG, Germania
\nRef. ANMDMR: 900\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSistem RMN \/ manufacturer Siemens Shenzhen Magnetic Resonance Ltd., China
\nRef. ANMDMR: 901\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nID-Anti-S, Test Serum ID-Anti-M, N, S, s, Fya, Fyb \/ manufacturer DiaMed GmbH, Elve\u021bia
\nRef. ANMDMR: 902\/25<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nVITUS-Fi Distal Fibula Nail \u00d8 3.0mm, L 110mm \/ manufacturer Dieter Marquardt Medizintechnik GmbH, Germania
\nRef. ANMDMR: 903\/25<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nInstrument implantare proteze Prevision Instruments \/ manufacturer Aesculap AG, Germania
\nRef. ANMDMR: 904\/25<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nPadele de defibrilare F7987W \/ manufacturer FIAB SpA, Italia
\nRef. ANMDMR: 935\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nGETINGE 88-5 Washer disinfector \/ manufacturer Getinge Disinfection AB, Suedia
\nRef. ANMDMR: 936\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSisteme CT Brilliance, Ingenuity, IQon Spectral CT\/ manufacturer Philips Medical Systems Nederland B.V., \u021a\u0103rile de Jos
\nRef. ANMDMR: 937\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nFortress Introducer Sheath System \/ manufacturer Contract Medical International GmbH (dba Heraeus Medevio), Germania
\nRef. ANMDMR: 938\/25<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nInstrument monitorizare functii vitale: ARGUS PB-3000 \/ manufacturer Schiller AG, Elve\u021bia
\nRef. ANMDMR: 939\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nARTIS pheno\/ manufacturer Siemens Healthcare GmbH, Germania
\nRef. ANMDMR: 942\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSta\u021bii de anestezie Atlan\/ manufacturer Dr\u00e4gerwerk AG & Co. KGaA, Germania
\nRef. ANMDMR: 943\/25<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nReusable trocar System \/ manufacturer Aesculap AG, Germania
\nRef. ANMDMR: 944\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nXVIVO Liver Assist Perfusion Set\u2122\/ manufacturer XVIVO B.V., \u021a\u0103rile de Jos
\nRef. ANMDMR: 945\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSisteme CT: Brilliance, Ingenuity \u0219i IQon Spectral \/ manufacturer Philips Medical Systems Nederland B.V., \u021a\u0103rile de Jos
\nRef. ANMDMR: 946\/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 \/ AUGUST 2025 PRODUCT RECALL Denti Dental Implant System \/ manufacturer DenTi System KFT, Ungaria […]<\/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-11228","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\/11228","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=11228"}],"version-history":[{"count":1,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/posts\/11228\/revisions"}],"predecessor-version":[{"id":11234,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/posts\/11228\/revisions\/11234"}],"wp:attachment":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/media?parent=11228"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/categories?post=11228"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/tags?post=11228"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}