{"id":10792,"date":"2025-05-27T12:26:43","date_gmt":"2025-05-27T09:26:43","guid":{"rendered":"https:\/\/www.anm.ro\/en\/?page_id=10792"},"modified":"2025-08-04T09:01:41","modified_gmt":"2025-08-04T06:01:41","slug":"sumarul-notificarilor-in-materie-de-siguranta-in-teren-aprilie-2025","status":"publish","type":"post","link":"https:\/\/www.anm.ro\/en\/sumarul-notificarilor-in-materie-de-siguranta-in-teren-aprilie-2025\/","title":{"rendered":"Summary of field safety notifications \/ APRIL 2025"},"content":{"rendered":"

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

USER INFORMATION<\/strong>
\nSistem de anestezie Carestation 620\/650\/650c \u0219i 750\/750c \/ manufacturer Datex-Ohmeda, Inc, SUA
\nRef. ANMDMR: 106\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSistem RMN \u2013 Mas\u0103 pacienti\/ manufacturer Siemens Healthcare GmbH, Germania
\nRef. ANMDMR: 124\/25<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nImplant dentar Microcone NI \/ manufacturer MEDENTiKA GmbH, Germania
\nRef. ANMDMR: 129\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nCateter cu balon intraaortic: Linear, Mega, Sensation, & Sensation Plus IAB \/ manufacturer Datascope Corporation, SUA
\nRef. ANMDMR: 132\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nMonitor pentru semne vitale Welch Allyn Connex (CVSM), electrocardiograf CP150 \u0219i accesoriu pentru monitorul spot Connex al Panoului de energiei (APM) \/ manufacturer Welch Allyn, Inc., SUA
\nRef. ANMDMR: 141\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nLinkSymphoKnee \/ manufacturer Waldemar Link GmbH & Co.KG
\nRef. ANMDMR: 142\/25<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nHigh Flow Double Lumen ST Catheter 13 Fr \/ manufacturer Joline GmbH & Co. KG, Germania
\nRef. ANMDMR: 155\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nPanou BIOFIRE\u00ae de identificare a hemoculturii 2 (BCID2) \/ manufacturer BioFire Diagnostics, LLC, SUA
\nRef. ANMDMR: 156\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSystem 6\/7\/8\/9 Reciprocating \/ Sternum Saw \/ manufacturer Stryker Instruments a division of Stryker Corporation, SUA
\nRef. ANMDMR: 157\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSistem laser Soltive \/ manufacturer Gyrus ACMI, Inc. (Olympus Surgical Technologies America), SUA
\nRef. ANMDMR: 158\/25<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nRocket Thoracentesis Catheter 6FG & 8FG \/ manufacturer Rocket Medical PLC,
\nRef. ANMDMR: 175\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nVenue Go, Venue Fit \/ manufacturer GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC, SUA
\nRef. ANMDMR: 176\/25<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nAc sau set sutur\u0103 – PDS II\u2122, PDS Plus\u2122, PROLENE\u2122 \u0219i ETHIBOND EXCEL\u2122\/ manufacturer Ethicon, LLC, SUA
\nRef. ANMDMR: 185\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nCompoStop\u2122 Platelet Storage Systems \/ manufacturer Fresenius Kabi AG, Germania
\nRef. ANMDMR: 190\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nDORO\u00ae Easy-Connect Navigation Adapter \/ manufacturer pro med instruments GmbH, Germania
\nRef. ANMDMR: 193\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nHemapatch Woven \/ manufacturer Intervascular SAS, Fran\u021ba
\n Ref. ANMDMR: 197\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nBiograph mMR \/ manufacturer Siemens Healthcare GmbH, Germania
\nRef. ANMDMR: 201\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nAirLife\u2122 Infant Heated Wire Circuits \/ manufacturer Vyaire Medical, Inc, SUA
\nRef. ANMDMR: 208\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nKliniTray \/ manufacturer Klinika Medical GmbH, Germania
\nRef. ANMDMR: 209\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\n Bracketi ortodontici – Legend Medium Roth \/ manufacturer GC Orthodontics Europe GmbH, Germania
\nRef. ANMDMR: 210\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nAparat de hemodializ\u0103 – valva (V84) \/ manufacturer Fresenius Medical Care AG, Germania
\nRef. ANMDMR: 213\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nPlus Initial Drill \/ manufacturer JJGC Ind\u00fastria e Com\u00e9rcio de Materiais Dent\u00e1rios S.A., Brazilia
\nRef. ANMDMR: 215\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nMicrostream Advance, VitaLine, FilterLine \/ manufacturer Philips Medizin Systeme B\u00f6blingen GmbH, Germania
\nRef. ANMDMR: 219\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nUHI-4 High Flow Insufflation Unit \/ manufacturer Olympus Medical Systems Corporation, Japonia
\nRef. ANMDMR: 222\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nTegaderm\u2122 Film \u2013 Transparent Film Dressing \/ manufacturer 3M Deutschland GmbH, Germania
\nRef. ANMDMR: 224\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSophie 2020 \/ manufacturer Fritz Stephan GmbH, Germania
\nRef. ANMDMR: 225\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nREMISOL Advance \/ manufacturer Normand-Info SASU, Fran\u021ba
\nRef. ANMDMR: 226\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nCentricity High Acuity Anesthesia \/ Critical Care \/ manufacturer GE Healthcare Finland Oy, Finlanda
\nRef. ANMDMR: 227\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nCateter Neurovent-PTO \/ manufacturer RAUMEDIC AG, Germania
\nRef. ANMDMR: 235\/25<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nFlexcel\u2122 Carotid Shunt \/ manufacturer LeMaitre Vascular, Inc., SUA
\nRef. ANMDMR: 245\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nmyQA iON \/ manufacturer IBA Dosimetry GmbH, Germania
\nRef. ANMDMR: 253\/25<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nTufTex\u00ae Over-the-Wire Embolectomy Catheter, Pruitt\u00ae Occlusion Catheter, Pruitt\u00ae Irrigation Occlusion Catheter \/ manufacturer LeMaitre Vascular, Inc., SUA
\nRef. ANMDMR: 261\/25<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nToric Intraocular Lenses (repacked units) \/ manufacturer Carl Zeiss Meditec AG, Germania
\nRef. ANMDMR: 268\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nCreatinine \/ manufacturer Beckman Coulter Inc., SUA
\nRef. ANMDMR: 285 \/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nCardiosave Intra-Aortic Balloon Pumps \/ manufacturer Datascope Corp., SUA
\nRef. ANMDMR: 296\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nCardiohelp System \/ manufacturer Maquet Cardiopulmonary GmbH, Germania
\nRef. ANMDMR: 300\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nORTHO VISION Analyzers \/ manufacturer QuidelOrtho (Ortho Clinical Diagnostics Inc), SUA
\nRef. ANMDMR: 303\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nTempus Pro \/ manufacturer Remote Diagnostic Technologies Ltd., Marea Britanie
\nRef. ANMDMR: 307\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nTempus Pro \/ manufacturer Remote Diagnostic Technologies Ltd., Marea Britanie
\nRef. ANMDMR: 308\/25<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nLentile intraoculare: enVista Aspire\u2122 \/Toric\/ Enhanced Monofocal\/Monofocal Toric\/ SimplifEye Preloaded Combo Kit \/ SimplifEye Preloaded Combo Kit Toric \/ manufacturer Bausch & Lomb Incorporated, SUA
\nRef. ANMDMR: 326\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nEndopath Echelon\u2122 Vascular White Reload \/ manufacturer ETHICON ENDO-SURGERY, LLC, SUA
\nRef. ANMDMR: 381\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSistem RM cu tunel de 60 cm l\u0103\u021bime \/ manufacturer Philips Medical Systems Nederland B.V., Olanda
\nRef. ANMDMR: 428\/25<\/span><\/a>, 428C\/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 \/ APRIL 2025 USER INFORMATION Sistem de anestezie Carestation 620\/650\/650c \u0219i 750\/750c \/ manufacturer Datex-Ohmeda, […]<\/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-10792","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\/10792","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=10792"}],"version-history":[{"count":2,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/posts\/10792\/revisions"}],"predecessor-version":[{"id":10949,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/posts\/10792\/revisions\/10949"}],"wp:attachment":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/media?parent=10792"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/categories?post=10792"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/tags?post=10792"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}