{"id":11312,"date":"2025-10-21T12:34:39","date_gmt":"2025-10-21T09:34:39","guid":{"rendered":"https:\/\/www.anm.ro\/en\/?p=11312"},"modified":"2025-10-21T12:40:26","modified_gmt":"2025-10-21T09:40:26","slug":"sumarul-notificarilor-in-materie-de-siguranta-in-teren-septembrie-2025","status":"publish","type":"post","link":"https:\/\/www.anm.ro\/en\/sumarul-notificarilor-in-materie-de-siguranta-in-teren-septembrie-2025\/","title":{"rendered":"Summary of field safety notifications \/ SEPTEMBER 2025"},"content":{"rendered":"

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

USER INFORMATION<\/strong>
\nExtension lines for single use \/ manufacturer Zibo Qiaosend Medical Articles Co., Ltd., China
\nRef. ANMDMR: 674\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSisteme da Vinci X \u0219i Xi \/ manufacturer Intuitive Surgical, Inc., SUA
\nRef. ANMDMR: 691\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nStimulatoare cardiace ACCOLADE\u2122\/ manufacturer Cardiac Pacemaker Inc, SUA
\nRef. ANMDMR: 941\/25<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nSpare parts for syringe pumps: Drive complete PSP, green claws, Spaceplus Perfusor Drive complete and Spaceplus Perfusor Drive Head with Claws & Tube \/ manufacturer B.Braun Melsungen AG, Germania
\nRef. ANMDMR: 971\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nCorpuls3 \/ manufacturer GS Elektromedizinische Ger\u00e4te G. Stemple GmbH, Germania
\nRef. ANMDMR: 991\/25<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nReconstruction plates \/ manufacturer KLS Martin SE & Co. KG, Germania
\nRef. ANMDMR: 1009\/25<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nREUSABLE TROCAR SYSTEM \/ manufacturer Aesculap AG, Germania
\nRef. ANMDMR: 1026\/25<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nProteza vascular\u0103 Vascugraft Flow \/ manufacturer B. Braun Melsungen AG, Germania
\nRef. ANMDMR: 1027\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSoftware Ashvins variant HEYEX 2 \/ HEYEX PACS \/ manufacturer MedicalCommunications GmbH, Germania
\nRef. ANMDMR: 1048\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSTA Liatest D-Di Plus \/ manufacturer Diagnostica Stago, Fran\u021ba
\nRef. ANMDMR: 1049\/25<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nGeneratoare VNS Therapy\u2122 SenTiva\u2122 \/ SenTiva Duo\u2122 \/ manufacturer LivaNova USA, Inc., SUA
\nRef. ANMDMR: 1050\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nBronhoscop\/ manufacturer Olympus Medical Systems Corporation, Japonia
\nRef. ANMDMR: 1065\/25<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nProtez\u0103 genunchi LinkSymphoKnee \/ manufacturerWaldemar Link GmbH & Co.KG, Germania
\nRef. ANMDMR: 1066\/25<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nAeroWalk Carbon Rollator \/ manufacturer Drive Medical GmbH & Co.KG, Germania
\nRef. ANMDMR: 1068\/25<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nStent periferic RENZAN\u2122 \/ manufacturer MicroVention Europe SARL, Fran\u021ba
\nRef. ANMDMR: 1069\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nDefibrilator extern Defigard HD-7\/ manufacturer Schiller Medical, Fran\u021ba
\nRef. ANMDMR: 1094\/25<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nStimuLong Sono II Sets \/ manufacturer PAJUNK GmbH Medizintechnologie, Germania
\nRef. ANMDMR: 1100\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nFDR Visionary Suite \/ manufacturer SHIMADZU Corporation, Japonia
\nRef. ANMDMR: 1135\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nBlue sail EndoBule Endoscopic Stapler \/ manufacturer Changzhou Tongchuang Medical Instrument Technology Co., Ltd., China
\nRef. ANMDMR: 1136\/25<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nAtlantis intraoral feature locating object for suprastructures (IO FLO-S)\/ manufacturer Dentsply Implants Manufacturing GmbH, Germania
\n Ref. ANMDMR: 1137\/25<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nNeodent GM Helix Implant \/ manufacturer Neodent – JJGC Ind\u00fastria e Com\u00e9rcio de Materiais Dent\u00e1rios S.A., Brazilia
\nRef. ANMDMR: 1144\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nHeater Unit HU 35 \/ manufacturer Maquet Cardiopulmonary GmbH, Germania
\nRef. ANMDMR: 1151\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nCateter de abla\u021bie TactiFlex\u2122 Sensor Enabled\u2122 \/ manufacturer Abbott, SUA
\nRef. ANMDMR: 1160\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSistemele Philips Allura Xper, Allura CV20 \u0219i Allura Centron\/ manufacturer Philips Medical Systems Nederland BV., \u021a\u0103rile de Jos
\nRef. ANMDMR: 1161\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSistem Philips Allura\/ manufacturer Philips Medical Systems Nederland BV, \u021a\u0103rile de Jos
\nRef. ANMDMR: 1162\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSistem anestezie Atlan \/ manufacturer Dr\u00e4gerwerk AG & Co. KGaA, Germania
\nRef. ANMDMR: 1181\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nVyntus products with SNIP\/RHINO Option \/ manufacturer Jaeger Medical GmbH, Germania
\nRef. ANMDMR: 1182\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nAirvo 2 and myAirvo 2 \/ manufacturer Fisher & Paykel Healthcare Ltd, Noua Zeeland\u0103
\nRef. ANMDMR: 1196\/25<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nHygenic Dental Dam \/ manufacturer The Hygenic Company, LLC, SUA
\nRef. ANMDMR: 1201\/25<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\n Sonde Vitrectomie ULTRAVIT\u00ae \u0219i HYPERVIT\u00ae \/ manufacturer Alcon Laboratories Inc., SUA
\nRef. ANMDMR: 1213\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nAutomated Impella Controller for Impella Catheter \/ manufacturer Abiomed Inc., SUA
\nRef. ANMDMR: 1223\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nCharging unit mounted W\/T AC TS7500 \/ manufacturer Baxter Medical Systems GmbH + Co. KG, Germania
\nRef. ANMDMR: 1224\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nUromed Silicone Balloon Catheter \/ manufacturer UROMED Kurt Drews KG, Germania
\nRef. ANMDMR: 1235\/25<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nImplant dentar Neodent GM Helix Implant \/ manufacturer JJGC Ind\u00fastria e Com\u00e9rcio de Materiais Dent\u00e1rios S.A., Brazilia
\nRef. ANMDMR: 1236\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nDexcom G6 iOS App \/ manufacturer Dexcom, Inc., SUA
\nRef. ANMDMR: 1241\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSharesource Claria application – Homechoice Claria automated peritoneal dialysis (APD) \/ manufacturer Baxter Healthcare SA, SUA
\nRef. ANMDMR: 1243\/25<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nLuer bone rongeur 17cm curved \/ manufacturer Tekno-Medical Optik-Chirurgie GmbH; Germania
\nRef. ANMDMR: 1246\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nAlinity hq Analyzer \/ manufacturer Abbott Laboratories, SUA
\nRef. ANMDMR: 1247\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nHeartSine samaritan Pad-Pak and Pediatric-Pak \/ manufacturer Medical (Heartsine Technologies Ltd.), Marea Britanie
\nRef. ANMDMR: 1248\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nBRAF 600\/601 StripAssay \/ manufacturer ViennaLab Diagnostics GmbH, Austria
\nRef. ANMDMR: 1280\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nBronhofibroscopul OLYMPUS \/ manufacturer Olympus Medical Systems Corporation, Japonia
\nRef. ANMDMR: 1283\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nChemoLock\u2122 Port \/ manufacturer ICU Medical Inc, SUA
\nRef. ANMDMR: 1285\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nMADSEN AccuScreen TEOAE\/DPOAE\/ABR Probe \/ manufacturer Path Medical GmbH, Germania
\nRef. ANMDMR: 1286\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSta\u021bie Central\u0103 Carescape\u2122 \/ manufacturer GE Medical Systems Information Technologies, Inc., SUA
\nRef. ANMDMR: 1288\/25<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nPompa insulina Tandem Diabetes Care\u2122 t:slim X2 \/ manufacturer Tandem Diabetes Care, Inc., SUA
\nRef. ANMDMR: 1294\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nEschweiler combiline \/ Eschweiler modularPro with Glucose and\/or Lactat Sensors \/ manufacturer Eschweiler GmbH & Co. KG, Germania
\nRef. ANMDMR: 1295\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nBiosteon Screw \/ manufacturer Biocomposites LTD, Marea Britanie
\nRef. ANMDMR: 1296\/25<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nSuportul pentru nas original furnizat cu lupa Dragonfly\u2122 sau Phantom\u2122 \/ manufacturer Metrex Research LLC dba Orascoptic, SUA
\nRef. ANMDMR: 1312\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nMassCheck\u00ae Dried Blood Spot Control Bi-Level I+II \/ manufacturer Chromsystems Instruments & Chemicals GmbH, Germania
\nRef. ANMDMR: 1325\/25<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nRezerv\u0103 inteligent\u0103 cu v\u00e2rf curbat \u0219i diametru mic Signia\u2122 Medtronic \/ manufacturer Covidien llc, SUA
\nRef. ANMDMR: 1326\/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 \/ SEPTEMBER 2025 USER INFORMATION Extension lines for single use \/ manufacturer Zibo Qiaosend Medical […]<\/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-11312","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\/11312","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=11312"}],"version-history":[{"count":1,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/posts\/11312\/revisions"}],"predecessor-version":[{"id":11314,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/posts\/11312\/revisions\/11314"}],"wp:attachment":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/media?parent=11312"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/categories?post=11312"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/tags?post=11312"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}