{"id":10638,"date":"2025-03-24T15:02:19","date_gmt":"2025-03-24T12:02:19","guid":{"rendered":"https:\/\/www.anm.ro\/en\/?page_id=10638"},"modified":"2025-08-04T09:53:04","modified_gmt":"2025-08-04T06:53:04","slug":"sumarul-notificarilor-in-materie-de-siguranta-in-teren-octombrie-2024","status":"publish","type":"post","link":"https:\/\/www.anm.ro\/en\/sumarul-notificarilor-in-materie-de-siguranta-in-teren-octombrie-2024\/","title":{"rendered":"Summary of field safety notifications \/ OCTOMBER 2024"},"content":{"rendered":"

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

USER INFORMATION<\/strong>
\nReusable and Single Use Flow Sensors \/ manufacturer SLE Ltd, Germania
\nRef. ANMDMR: 305.797c\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nCoaguChek PT 2×24 Test \/ manufacturer Roche Diagnostics GmbHa, Germania
\nRef. ANMDMR: 305.989\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nMas\u0103 de opera\u021bie TruSystem 7000 \u2013 Semnal de siguran\u021b\u0103 pentru evenimente termice legate de baterie \/ manufacturer Baxter Medical Systems GmbH + Co. KG, Germania
\nRef. ANMDMR: 305.990\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nUroPass\u00ae Ureteral Access Sheath Set \/ manufacturer Gyrus ACMI, Inc. (Olympus Surgical Technologies America), SUA
\nRef. ANMDMR: 305.993\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSterilizable Internal Defibrillation Paddles \/ manufacturer Stryker Medical (Physio-Control, Inc.), SUA
\nRef. ANMDMR: 306.012\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nTrilogy Evo, Trilogy Evo O2, and Trilogy EV300 \/ manufacturer Philips Respironics, Inc., SUA
\nRef. ANMDMR: 306.013\/2024<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nrespons\u00ae940 systems \/ manufacturer DiaSys Diagnostic Systems GmbH, Germania
\nRef. ANMDMR: 306.102\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nBronchovideoscope, EVIS EXERA III Gastrointestinal Videoscope, EVIS EXERA III Small Intestinal Videoscope, Gastrointestinal Videoscope \/ manufacturer Olympus Medical Systems Corporation, Japonia
\nRef. ANMDMR: 306.110\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nVentilator ParaPAC plus\u2122 Model 300 \u0219i Model 310\/ manufacturer Smiths Medical ASD Inc. (currently “ICU Medical Inc.”), SUA
\nRef. ANMDMR: 306.124\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nVentilator ParaPAC plus\u2122 Model 300 \u0219i Model 310\/ manufacturer Smiths Medical ASD Inc. (currently “ICU Medical Inc.”), SUA
\nRef. ANMDMR: 306.125\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\n Carbon fiber side guards with untrimmed edge\/ manufacturer Panthera AB, Suedia
\nRef. ANMDMR: 306.126\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nLIFE 21 apheresis unit \/ manufacturer Miltenyi Biotec B.V. & Co. KG, Germania
\nRef. ANMDMR: 306.142\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nUroPass\u00ae Ureteral Access Sheath Set \/ manufacturer Gyrus ACMI, Inc. (Olympus Surgical Technologies America), SUA
\nRef. ANMDMR: 306.153\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nKit de diagnosticare in vitro (IVDD) Mentype\u00ae AMLplexQS \/ manufacturer BIOTYPE GmbH, Germania
\nRef. ANMDMR: 306.202\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nAlegria 2 \/ manufacturer ORGENTEC Diagnostika GmbH, Germania
\nRef. ANMDMR: 306.204\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nPOLARx\u2122 and POLARx\u2122 FIT Cryoablation Catheter – Instructions for Use \/ manufacturer Boston Scientific Corporation, SUA
\nRef. ANMDMR: 306.209\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nUlei siliconic \/manufacturer D.O.R.C. Dutch Ophthalmic Research Center (International) B.V., Olanda
\nRef. ANMDMR: 306.210\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nLamp\u0103 chirurgical\u0103 Merivaara Q-FLOW \/ manufacturer Merivaara Corporation, Finlanda
\nRef. ANMDMR: 306.216\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nARCHITECT i2000SR Processing Module\/ manufacturer Abbott Laboratories, SUA
\nRef. ANMDMR: 306.253\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nJasper\u2122 HPLC System \/ manufacturer AB SCIEX Pte. Ltd., Singapore
\nRef. ANMDMR: 306.273\/24<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nNetwork-isolator Cat.6A for healthcare \/ manufacturer EFB Elektronik GmbH, Germania
\nRef. ANMDMR: 306.278\/24<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nMAJ-1555 Single Use Biopsy Valve \/ manufacturer Olympus Medical Systems Corporation, Japonia
\nRef. ANMDMR: 306.279\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nrespons\u00ae940 systems\/ manufacturer Dh Healthcare Gmbh, Germania
\nRef. ANMDMR: 306.281\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nrespons\u00ae940 systems \/ manufacturer DiaSys Diagnostic Systems GmbH, Germania
\nRef. ANMDMR: 306.286\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSisteme de pomp\u0103 MiniMedTM seria 600 \u0219i seria 700 \/ manufacturer Medtronic Minimed, SUA
\nRef. ANMDMR: 306.366\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nCA 72-4 ELISA \/ manufacturer IBL International GmbH, Germania
\nRef. ANMDMR: 306.371\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nOlympus GIF-1TH190 Gastrointestinal Videoscope \/ manufacturer Olympus Medical Systems Corporation, Japonia
\nRef. ANMDMR: 306.380\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSD UroColor 10\/ UroColor 10, SD UroColor 11\/ UroColor 11 \/ manufacturer Abbott Diagnostics Korea Inc. (Old name : Standard Diagnostics, Inc.), Koreea
\nRef. ANMDMR: 306.383\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nPotential Loss of Electrical Grounding – IntelliVue Patient Monitor Power Supply \/ manufacturer Philips Medizin Systeme Boblingen GmbH, Germania
\nRef. ANMDMR: 306.389\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nFlow Sensors Nebulized Aerosol Deposition with Trilogy Evo, Trilogy Evo O2, Trilogy EV300\/ manufacturer Philips Respironics, Inc, SUA
\nRef. ANMDMR: 306.391\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nUsers of mint Lesion\u2122 versions from 3.8.6 up to and including 3.9.2 \/ manufacturer Mint Medical GmbH, Germania
\nRef. ANMDMR: 306.392\/24<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nNavitor\u2122 Transcatheter Aortic Heart valves \/ manufacturer Abbott Medical, SUA
\nRef. ANMDMR: 306.393\/24<\/span><\/a>, 306.393C\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nNutrifix Bag \u2013 Infusomat Space Line ENFit \/ manufacturer B.Braun Melsungen AG, Germania
\nRef. ANMDMR: 306.396\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nCentricity Universal Viewer Zero Footprint Client (ZFP) \/ manufacturer GE Healthcare, SUA
\nRef. ANMDMR: 306.425\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nTCM5 monitor \/ manufacturer Radiometer Medical ApS, Danemarca
\nRef. ANMDMR: 306.426\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nDepunere de aerosoli ob\u0163inu\u0163i prin nebulizare pe senzorii de debit Trilogy Evo, Trilogy Evo O2, Trilogy EV300 \/ manufacturer Philips Respironics, Inc., SUA
\nRef. ANMDMR: 306.433\/24<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nCutter agresiv, Rezector cu raz\u0103 complet\u0103, Lam\u0103 r\u0103zuitor agres. Pro Line, Trepan rotund, Trepan cilindric agresiv, Trepan cilindric pentru finisare, Trepan cilindric cu semi-capac protector, Trepan cilindric agresiv\/ manufacturer KARL STORZ SE & Co. KG, Germania
\nRef. ANMDMR: 306.435\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nnal von minden Drug-Screen\u00ae COC 300 Test \/ manufacturer nal von minden GmbH, Germania
\nRef. ANMDMR: 306.449\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nBiPAP A40 Pro, BiPAP A40 EFL and BiPAP A30 EFL Ventilators Alarm Malfunction \/ manufacturer Philips Respironics, Inc., SUA
\nRef. ANMDMR: 306.489\/24<\/span><\/a><\/p>\n

PRODUCT RECALL <\/strong>
\nThe Femoral ACL Marking Hook, AM Portal, 7 mm Offset \/ manufacturer Arthrex INC, SUA
\nRef. ANMDMR: 306.502\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSoftware Update for Alegria 2 \/ manufacturer ORGENTEC Diagnostika GmbH, Germania
\nRef. ANMDMR: 306.503\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSistemele Zenition 50 \u015fi Zenition 70 \/ manufacturer Philips Medical Systems Nederland BV, Olanda
\nRef. ANMDMR: 306.505\/24<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nOpraclean Ribbon Gauze for packing with Iodoform 5m x 1 cm \/ manufacturer Lohmann & Rauscher International GmbH & Co. KG, Germania
\nRef. ANMDMR: 306.534\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nKayserBetten GmbH & Co. KG – KayserBett OLAF 98, KayserBett OLAF 135 \/ manufacturer KayserBetten GmbH & Co. KG, Germania
\nRef. ANMDMR: 306.535\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nKayserBett OLAF paediatric care bed \/ manufacturer ayserBetten GmbH & Co. KG, Germania
\nRef. ANMDMR: 306.536\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nWound care dressings \/ manufacturer Advanced Medical Solutions, Marea Britanie
\nRef. ANMDMR: 306.563\/24<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nMedizym\u00ae anti-GAD M \/ manufacturer Medipan GmbH, Germania
\nRef. ANMDMR: 306.564\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nUniversal Remote Control \/ manufacturer MAQUET GmbH, Germania
\nRef. ANMDMR: 306.565\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nIncidin Oxywipe S \/ manufacturer Ecolab Deutschland GmbH, Germania
\nRef. ANMDMR: 306.567\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nEarlyCDT Lung Cancer Test Kit \/ manufacturer Freenome Ltd, Germania
\nRef. ANMDMR: 306.568\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nReplacement of Batteries for Orchestra and Pilot ranges \/ manufacturer Fresenius Kabi AG, Germania
\nRef. ANMDMR: 306.569\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nCatetere PowerPICCsingle lumen 4Fr \/ manufacturer Bard Access Systems, Inc, SUA
\nRef. ANMDMR: 306.695\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\n Atlan anaesthesia workstations\/ manufacturer Dr\u00e4gerwerk AG & Co. KGaA, Germania
\nRef. ANMDMR: 306.700\/24<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nTM-CA 72-4 ELISA \/ manufacturer DRG Instruments GmbH, Germania
\nRef. ANMDMR: 306.701\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nGeneProof Aspergillus PCR Kit \/ manufacturer GeneProof a.s., Cehia
\nRef. ANMDMR: 306.702\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nOlympus Laser Cystoscope \/ manufacturer Olympus Winter & Ibe GmbH, Germania
\nRef. ANMDMR: 306.705\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nPaediatric care bed KayserBett EMMA, KayserBett IDA \/ manufacturer KayserBetten GmbH & Co. KG, Germania
\nRef. ANMDMR: 306.706\/24<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nHemospray Endoscopic Hemostat \/ manufacturer Cook Endoscopy\/Wilson Cook Medical, Inc., SUA
\nRef. ANMDMR: 306.726\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\n ETD Premium PAA, ETD Premium GA \/ manufacturer Miele & Cie. KG, Germania
\nRef. ANMDMR: 306.728\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nmylife App \/ manufacturer SINOVO health solutions GmbH, Germania
\nRef. ANMDMR: 306.729\/24<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nAxillary Insertion Introducer and Introducer Kits – Risk of Infection \/ manufacturer Oscor Inc, SUA
\nRef. ANMDMR: 306.730\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nIntroduc\u0103tor \u0219i ghiduri reutilizabile pentru tuburi traheale\/ manufacturer ICU Medical Inc, SUA
\nRef. ANMDMR: 306.731\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nBD BACTEC\u2122 Blood Culture System, BD Phoenix\u2122 M50 Automated
\nMicrobiology System, BD MAX\u2122 System, BD COR\u2122 System, BD EpiCenter\u2122 Microbiology Data
\nManagement System, BD Synapsys\u2122 Informatics Solution \/ manufacturer Becton, Dickinson and Company, SUA
\nRef. ANMDMR: 306.735\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nRemote controlled radiology system: PLATINUM dRF (8L) \/ manufacturer APELEM, Fran\u021ba
\nRef. ANMDMR: 306.829\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nCistoscop cu laser Olympus \/ manufacturer Olympus Winter & Ibe GmbH, Germania
\nRef. ANMDMR: 306.856\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nDispozitive v\u00e2scochirurgicale oftalmice (OVD)- Visthesia 1.5% \/manufacturer Hyaltech Ltd, Germania
\nRef. ANMDMR: 307.128\/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 \/ OCTOMBER 2024 USER INFORMATION Reusable and Single Use Flow Sensors \/ manufacturer SLE Ltd, […]<\/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-10638","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\/10638","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=10638"}],"version-history":[{"count":3,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/posts\/10638\/revisions"}],"predecessor-version":[{"id":10945,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/posts\/10638\/revisions\/10945"}],"wp:attachment":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/media?parent=10638"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/categories?post=10638"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/tags?post=10638"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}