{"id":10915,"date":"2025-07-14T08:00:34","date_gmt":"2025-07-14T05:00:34","guid":{"rendered":"https:\/\/www.anm.ro\/en\/?page_id=10915"},"modified":"2025-08-04T09:00:00","modified_gmt":"2025-08-04T06:00:00","slug":"sumarul-notificarilor-in-materie-de-siguranta-in-teren-iunie-2025","status":"publish","type":"post","link":"https:\/\/www.anm.ro\/en\/sumarul-notificarilor-in-materie-de-siguranta-in-teren-iunie-2025\/","title":{"rendered":"Summary of field safety notifications \/ JUNE 2025"},"content":{"rendered":"

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

USER INFORMATION<\/strong>
\nDexcom One, Dexcom G7 and Dexcom One+ Receivers \/ manufacturer Dexcom, Inc. SUA
\nRef. ANMDMR: 411\/25<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nLifepearl\u2122 Drug Elutable Microspheres \/ manufacturer MicroVention Europe SARL, Franta
\nRef. ANMDMR: 495\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nBD FACS M\u0103rgele\u2122 de configurare \u00een 7 culori \/ manufacturer Becton, Dickinson and Company, SUA
\nRef. ANMDMR: 496\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nDexcom G7 iOS App version 2.7 \/ manufacturer Dexcom, Inc., SUA
\nRef. ANMDMR: 497\/25<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nSistem de dezinfectare cu peroxid 3% pentru lentile de contact \/ manufacturer DISOP S.A., Spania
\nRef. ANMDMR: 504\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nConsumabile produse de MEDTRON AG \/ manufacturer MEDTRON AG, Germania
\nRef. ANMDMR: 506\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSisteme cu ultrasunete: Versana Premier \/ LOGIQ F seria R3 \/ manufacturer GE Medical Systems (China) Co., Ltd., China
\nRef. ANMDMR: 508\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSistem Uroskop Omnia \/ Omnia Max \/ manufacturer Siemens Healthcare GmbH, Germania
\nRef. ANMDMR: 509\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nFiltre\/HME Dr\u00e4ger SafeStar Plus, TwinStar HEPA Plus \/ manufacturer Dr\u00e4gerwerk AG & Co. KGaA, Germania
\nRef. ANMDMR: 510\/25<\/span><\/a><\/p>\n

USER INFORMATION <\/strong>
\nCopeland\u00ae Fetal Scalp Electrode \/ manufacturer Rocket Medical PLC, Marea Britanie
\nREF. ANMDMR: 511\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nORBIS Medication 3.x \/ manufacturer DH Healthcare GmbH, Germania
\nRef. ANMDMR: 512\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSynapse PACS 7.4.x \/ manufacturer FUJIFILM Healthcare Americas Corporation
\nRef. ANMDMR: 513\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSoltive Laser System \/ manufacturer Gyrus ACMI, Inc. (Olympus Surgical Technologies America), SUA
\nRef. ANMDMR: 514\/25<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nLiaison\u00ae Biotrin Parvovirus B19 IgM \/ manufacturer Diasorin Italia S.p.A., Italia
\nRef. ANMDMR: 515\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nBIOFIRE BCID2 Panel \/ manufacturer BioFire Diagnostics, LLC, SUA
\nRef. ANMDMR: 516\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nORBIS Medication 3.x \/ manufacturer DH Healthcare GmbH, Germania
\nRef. ANMDMR: 517\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSisteme Philips Azurion R1.x \u0219i R2.x \/ manufacturer Philips Medical Systems Nederland BV, T\u0103rile de Jos
\nRef. ANMDMR: 522\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nDeepUnity PACSonWEB \/ manufacturer DH Healthcare GmbH, Germania
\nRef. ANMDMR: 524\/25<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nImpactor, iliac peg \/ manufacturer Peter Brehm GmbH, Germania
\nRef. ANMDMR: 526\/25<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nCanul\u0103 arterial\u0103 \/ manufacturer Edwards Lifesciences LLC, SUA
\nRef. ANMDMR: 527\/25<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\niGo2-125 Series Portable Oxygen Concentrator \/ manufacturer DeVilbiss Healthcare LLC, SUA
\nRef. ANMDMR: 530\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nPinnacle Radiation Therapy Planning System \/ manufacturer Philips Medical Systems (Cleveland), Inc., SUA
\nRef. ANMDMR: 531\/25<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nOne-piece Guedel airways \/ manufacturer IntersurgicaL Ltd., Marea Britanie
\nRef. ANMDMR: 532\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nDuodenoscop \/ manufacturer Olympus Medical Systems Corporation, Japonia
\nRef. ANMDMR: 533\/25<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nEmboLog S 450 mg \/ manufacturer Serumwerk Bernburg AG, Germania
\nRef. ANMDMR: 540\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nCateter IVUS digital \/ manufacturer Philips (Volcano Corporation), SUA
\nRef. ANMDMR: 541\/25<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nHeartSine samaritan\u00ae PAD 350P\/360P\/450P\/500P \/ manufacturer Medical (Heartsine Technologies Ltd.), Marea Britanie
\nRef. ANMDMR: 542\/25<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nOptiSite Arterial Cannula, Femoral Arterial Cannula \/ manufacturer Edwards Lifesciences LLC, SUA
\nRef. ANMDMR: 543\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nActualizare software: Medtronic CareLink\u2122 SmartSync\u2122 \/ manufacturer Medtronic Inc., SUA
\nRef. ANMDMR: 544\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nVIDAS\u00ae HIV DUO AG\/AB \/ manufacturer bioM\u00e9rieux SA, SUA
\nRef. ANMDMR: 545\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nActualizare software: Medtronic CareLink\u2122 SmartSync\u2122 \/ manufacturer Medtronic Inc., SUA
\nRef. ANMDMR: 546\/25<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nY-Piece Breathing Trainers \/ manufacturer Flexicare Medical LTD, Marea Britanie
\nRef. ANMDMR: 547\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nmRay \/ manufacturer mbits imaging GmbH, Germania
\nRef. ANMDMR: 548\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\naPTT Screen cobas t 600T, aPTT Lupus cobas t 600T, aPTT cobas t 600T \/ manufacturer Roche Diagnostics GmbH, Germania
\nRef. ANMDMR: 549\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\n Sisteme RMN : Vantage Orian MRT-1550, Vantage Elan MRT-2020, Vantage Titan MRT-1504 \/ manufacturer Canon Medical Systems Corporation, Japonia
\nRef. ANMDMR: 550\/25<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nSistem mobil de ridicare a pacien\u021bilor: Uno 102 EE, LikoLight, LikoScale and Viking XL\/L\/M Mobile Lift \/ manufacturer Liko AB, Suedia
\nRef. ANMDMR: 551\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nInPen Application App \/ manufacturer Medtronic Minimed, SUA
\nRef. ANMDMR: 552\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSprinter Cart (XL) \/ manufacturer Maquet Cardiopulmonary GmbH, Germania
\nRef. ANMDMR: 560\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nNellcor Bedside SpO2 Patient Monitoring System \/ manufacturer Covidien LLC, SUA
\nRef. ANMDMR: 561\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nORBIS Medication 3.x \/ manufacturer DH Healthcare GmbH, Germania
\nRef. ANMDMR: 562\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nDispozitivele Gelsoft Plus \u0219i Gelweave \/ manufacturer Vascutek Ltd, Marea Britanie
\nRef. ANMDMR: 563\/25<\/span><\/a><\/p>\n

USER INFORMATION <\/strong>
\nDatascope Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps (IABP) \/ manufacturer AGA Sanit\u00e4tsartikel GmbH, Germania
\nRef. ANMDMR: 564\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nPomp\u0103 de nutri\u021bie enteral\u0103: Easymoov6 \/ manufacturer MEDWIN FRANCE, Fran\u021ba
\nRef. ANMDMR: 565\/25 <\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSheath, 20Fr \/ manufacturer Trokamed GmbH, Germania
\nRef. ANMDMR: 566\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\n3mensio Workstation \/ manufacturer Pie Medical Imaging B.V., Olanda
\nRef. ANMDMR: 574\/25<\/p>\n

USER INFORMATION<\/strong>
\nPolycentric 4 BAR Manual Locking Knee \/ manufacturer Regal Prosthesis Ltd, China
\nRef. ANMDMR: 575\/25<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nNIO lntraosseous Device Adult \/ manufacturer \tWaismed ltd., Israel
\nRef. ANMDMR: 588\/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 \/ JUNE 2025 USER INFORMATION Dexcom One, Dexcom G7 and Dexcom One+ Receivers \/ manufacturer […]<\/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-10915","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\/10915","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=10915"}],"version-history":[{"count":2,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/posts\/10915\/revisions"}],"predecessor-version":[{"id":10917,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/posts\/10915\/revisions\/10917"}],"wp:attachment":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/media?parent=10915"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/categories?post=10915"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/tags?post=10915"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}