{"id":10739,"date":"2025-05-05T08:00:23","date_gmt":"2025-05-05T05:00:23","guid":{"rendered":"https:\/\/www.anm.ro\/en\/?page_id=10739"},"modified":"2025-08-04T09:02:05","modified_gmt":"2025-08-04T06:02:05","slug":"sumarul-notificarilor-in-materie-de-siguranta-in-teren-martie-2025","status":"publish","type":"post","link":"https:\/\/www.anm.ro\/en\/sumarul-notificarilor-in-materie-de-siguranta-in-teren-martie-2025\/","title":{"rendered":"Summary of field safety notifications \/ MARCH 2025"},"content":{"rendered":"

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

USER INFORMATION<\/strong>
\nProPort\u2122 Plastic Implantable Ports \/ manufacturer ICU Medical Inc, SUA
\nRef. ANMDMR: 56\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nDeepUnity PACSonWEB \/ manufacturer DH Healthcare GmbH, Germania
\nRef. ANMDMR: 57\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\n Reactiv ELISA Inhibin B Gen II \/ manufacturer Immunotech s.r.o., Cehia
\nRef. ANMDMR: 61\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nDiphoterine Lp \/ Hexafluorine Lp \/ manufacturer Prevor, Fran\u021ba
\nRef. ANMDMR: 62\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nHYBRID guidewire \/ manufacturer BALT EXTRUSION SAS, Franta
\nRef. ANMDMR: 63\/25<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nShiley\u2122 Adult Flexible Tracheostomy Tube with TaperGuard\u2122 Cuff Reusable Inner Cannula \/ manufacturer Medtronic Ireland Limited, Irlanda
\nRef. ANMDMR: 64\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nABL90 FLEX and ABL90 FLEX PLUS Analyzer \/ manufacturer Radiometer Medical ApS, Danemarca
\nRef. ANMDMR: 65\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nIntubation Oral\/Nasal Endotracheal Tube \/ manufacturer Smiths Medical ASD, Inc, SUA
\nRef. ANMDMR: 78\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nKocher forceps, included in the HARTMANN gynaecology and obstetrics sets \/ manufacturer Paul Hartmann AG, Germania
\nRef. ANMDMR: 80\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nMas\u0103 chirurgical\u0103 TruSystem 7500 \/ manufacturer Baxter Medical Systems GmbH + Co. KG, Germania
\nRef. ANMDMR: 81\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nDeepUnity Diagnost \/ manufacturer DH Healthcare GmbH, Germania
\nRef. ANMDMR: 82\/25<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nHeartMate 3 Mobile Power Unit (MPU) \/ manufacturer Thoratec Corporation, SUA
\nRef. ANMDMR: 85\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nFRED easyport \/ manufacturer SCHILLER AG, Elve\u021bia
\nRef. ANMDMR: 103\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nCarestation 600 and 750 Series \/ manufacturer Datex-Ohmeda, Inc, SUA
\nRef. ANMDMR: 106\/25<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nTLX\/TLX Guided Implant Driver \/ manufacturer Institut Straumann AG, Elve\u021bia
\nRef. ANMDMR: 108\/28<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nAlinity m System\/ manufacturer Abbott Molecular, Inc., SUA
\nRef. ANMDMR: 111\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\n IntelliVue Philips Patient Monitor 6000 series\/ manufacturer Philips Medizin Systeme B\u00f6blingen GmbH, Germania
\nRef. ANMDMR: 112\/25<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nDiamantschleifinstrumente Dental \/ manufacturer NTI-Kahla GmbH Rotary Dental Instruments, Germania
\nRef. ANMDMR: 113\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nCARDIOSAVE Hybrid \u2013 Ultrasonic Doppler \/ manufacturer MAQUET Cardiovascular, LLC, SUA
\nRef. ANMDMR: 117\/25<\/span>, 117C\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\n 3PLUS1\u00aeMultilevel Plasma Calibrator Set, MassTox\u00aeAntimycotic Drugs, MassCheck\u00aeAntimycotic Drugs \/ manufacturer Chromsystems Instruments & Chemicals GmbH, DE
\nRef. ANMDMR: 236\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nAnti-TPO \/ manufacturer ORGENTEC Diagnostika GmbH, Germania
\nRef. ANMDMR: 237\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nKit reactiv Access Vitamina B12 \/ manufacturer Beckman Coulter, Inc., SUA
\nRef. ANMDMR: 238\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nORBIS Medication 3.X \/ manufacturer DH Healthcare GmbH, Germania
\nRef. ANMDMR: 239\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nORBIS Medication 3.x \/ manufacturer DH Healthcare GmbH, Germania
\nRef. ANMDMR: 240\/25<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nCustom Tubing Packs – CTP \/ manufacturer Maquet Cardiopulmonary GmbH, DE
\nRef. ANMDMR: 241\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nAnti-TPO \/ manufacturer ORGENTEC Diagnostika GmbH, Germania
\nRef. ANMDMR: 242\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nHb-sensor type III complete \/ manufacturer ESCHWEILER GmbH & Co. KG
\nRef. ANMDMR: 243\/24<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nCartiva Synthetic Cartilage Implant (SCI) \/ manufacturer Cartiva Inc., SUA
\nRef. ANMDMR: 244\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSistem de monitorizare a nervilor NIM Vital\u2122 \/ manufacturer Medtronic Xomed, Inc., SUA
\nRef. ANMDMR: 281\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nMEONA Release V \/ manufacturer Mesalvo Freiburg GmbH, Germania
\nRef. ANMDMR: 282\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nDispozitivele Giraffe OmniBed \u0219i Giraffe OmniBed Carestation \/ manufacturer GE Healthcare, SUA
\nRef. ANMDMR: 283\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nGeneProof Aspergillus PCR Kit \/ manufacturer GeneProof a.s, Cehia
\nRef. ANMDMR: 315\/25<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nGb Onco EGFR \/ manufacturer Generi Biotech s.r.o, Cehia
\nRef. ANMDMR: 316\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nProgressa \/ manufacturer Hill-Rom, Inc., SUA
\nRef. ANMDMR: 317\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nAlinity m System \/ manufacturer Abbott Molecular, Inc., SUA
\nRef. ANMDMR: 318\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nDxC 500 AU Clinical Chemistry Analyzer\/ manufacturer Beckman Coulter Inc, SUA
\nRef. ANMDMR: 319\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nAnti-TPO IgG \/ manufacturer DIALAB – Produktion und Vertrieb von chemisch-technischen Produkten und Laborinstrumenten Gesellschaft m.b.H., Austria
\nRef. ANMDMR: 320\/25<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\n4F Amplatzer\u2122 TVLP \/ manufacturer Abbott Medical, SUA
\nRef. ANMDMR: 18676\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\n Mobile Phase A MassChrom\u00ae Amino Acid Analysis \/ manufacturer Chromsystems Instruments & Chemicals GmbH, Germania
\nRef. ANMDMR: 18720\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nMassChrom\u00ae AminoAcids and Acylcarnites from dried blood \/ manufacturer Chromsystems Instruments & Chemicals GmbH, Germania
\nRef. ANMDMR: 19830\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nCell-Dyn Ruby \/ manufacturer Abbott Laboratories, SUA
\nRef. ANMDMR: 20131\/25<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nHemospray Endoscopic Hemostat \/ manufacturer Cook Endoscopy \/ Wilson-Cook Medical, Inc., SUA
\nRef. ANMDMR: 20161\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nEndoflow\u00ae II \/ manufacturer Rocamed, Fran\u021ba
\nRef. ANMDMR: 20201\/25<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\n EVOK Femoral Stem – Standard Offset – Collarless – Cemented – Taper 12\/14 – Size 8 \/ manufacturer Amplitude, Fran\u021ba
\nRef. ANMDMR: 20202\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nDxC 500i Clinical Analyzer \/ manufacturer Beckman Coulter, Inc., SUA
\nRef. ANMDMR: 20203\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nEsophyX\u00ae Z+ \/ manufacturer Merit Medical Systems Inc., SUA
\nRef. ANMDMR: 20220\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nPF4 Enhanced\u00ae, PF4 IgG \/ manufacturer Immucor GTI Diagnostics (A Werfen Company), SUA
\nRef. ANMDMR: 20231\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nBioproteza Medtronic Evolut\u2122 PRO+\/FX\/FX+\/ manufacturer Medtronic CoreValve LLC, SUA
\nRef. ANMDMR: 20234\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nAnti-TPO IgG \/ manufacturer DIALAB – Produktion und Vertrieb von chemisch-technischen Produkten und Laborinstrumenten Gesellschaft m.b.H., Germania<\/span><\/a>
\nRef. ANMDMR: 20240\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nPlegiStore\u00ae, LungProtect\u00ae, CelProtect\u00ae, StoreProtect Plus\u00ae, StoreProtect\u00ae, PumpProtect\u00ae, Belzer UW\u00ae Cold Storage Solution (University of Wisconsin Solution), Belzer MPS\u00ae (UW Machine Perfusion Solution) \/ manufacturer Carnamedica Sp. z o.o., Polonia
\nRef. ANMDMR: 20242\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nCentricity Universal Viewer (UV), Centricity PACS-IW (PACS-IW), Centricity Radiology RA600 (RA600) \u0219i Centricity Cardiology CA1000 (CA1000) \/ manufacturer GE Healthcare, SUA
\nRef. ANMDMR: 20245\/25<\/span><\/a>, 20245C\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSistem mas\u0103 chirurgical\u0103 TruSystem 7500 \/ manufacturer Baxter Medical Systems GmbH + Co. KG, Germania
\nRef. ANMDMR: 20265\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nRX Cassette Cover \/ manufacturer Medline International France SAS, Fran\u021ba
\nRef. ANMDMR: 20267\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\n4Fr Single Lumen PowerPICC \/ manufacturer Bard Access Systems Incorporated, SUA
\nRef. ANMDMR: 20275\/25<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nStrappal\u00ae \/ manufacturer BSN Medical SAS, Fran\u021ba
\nRef. ANMDMR: 20281\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nKit reactiv Access Vitamina B12 \/ manufacturer Beckman Coulter, SUA
\nRef. ANMDMR: 20289\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSistemele de radiologie interven\u021bional\u0103 – modele: INFX-8000C, INFX-8000F, INFX-8000V, INFX-8000H \/ manufacturer Canon Medical Systems Corporation, Japonia
\nRef. ANMDMR: 20291\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nCGM Clinical Medication \/ manufacturer CompuGroup Medical Software GmbH, Germania
\nRef. ANMDMR: 20300\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nMeona – Release V \/ manufacturer Mesalvo Freiburg GmbH, Germania
\nRef. ANMDMR: 20301\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nBivona\u00ae TTS\u2122 Adjustable Neck Flange Hyperflex\u2122 Tracheostomy Tube \/ manufacturer Smiths Medical ASD, Inc, SUA
\nRef. ANMDMR: 20305\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSisteme de tomografie computerizat\u0103 Revolution CT \u0219i Revolution Apex \/ manufacturer GE Medical Systems LLC, USA
\nRef. ANMDMR: 20316\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nKit tuburi pentru oxigenator Hilite 7000 LT \/ manufacturer XENIOS AG, Germania
\nRef. ANMDMR: 20325\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\n Medisa Automated Endoscope Reprocessors (AERs) \/ manufacturer Cantel Medical (Italy) S.r.l., Italia
\nRef. ANMDMR: 20337\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\n4Fr Single Lumen PowerPICC \/ manufacturer Bard Access Systems, Inc, SUA
\nRef. ANMDMR: 20339\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nisla-cassis \/ manufacturer Engelhard Arzneimittel GmbH & Co. KG, Germania
\nRef. ANMDMR: 20369\/25<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nClimber Guiding Catheter 5F EBU 3.5. \/ manufacturer PendraCare International B.V., Olanda
\nRef. ANMDMR: 20370\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nIntelliSpace Cardiovascular 7.0 \/ manufacturer Philips Medical Systems Nederland B.V., Olanda
\nRef. ANMDMR: 20371\/25<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nKnieorthese ADVAGOknee \/ manufacturer OPED GmbH, Germania
\nRef. ANMDMR: 20372\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nVDR4 Phasitron Breathing Circuit Kit \/ manufacturer Percussionaire Corporation, SUA
\nRef. ANMDMR: 20376\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\n Manusi examinare Halyard Purezero Limon\/ manufacturer O&M Halyard, Inc., SUA
\nRef. ANMDMR: 20381\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nRapid-VIDITEST Giardia \/ manufacturer VIDIA spol sro, Cehia
\nRef. ANMDMR: 20386\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nActualizare la comunicarea GE HealthCare privind aparatele de anestezie Aisys CS2, Avance CS2, Avance CS2 Pro, Aisys, Avance, Amingo, Aespire 100, Aespire View, Aespire 7900 \u0219i Aespire 7100 echipate cu ie\u0219ire de gaz comun\u0103 auxiliar\u0103 \/ manufacturer Datex-Ohmeda, Inc., SUA
\nRef. ANMDMR: 20388\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSistem Philips DXR \/ manufacturer Philips Healthcare (Suzhou) Co., Ltd, China
\nRef. ANMDMR: 20391\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nMedistim L15 Ultrasound Imaging probe \/ manufacturer Medistim ASA, Norvegia
\nRef. ANMDMR: 20406\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\n Single use endoscope cleaning brush \/ manufacturer LTA Medical (Getinge Company), Fran\u021ba
\nRef. ANMDMR: 20410\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nAortic Root Cannula included in Medline Sterile Procedure Trays \/ manufacturer Medline International France SAS, Fran\u021ba
\nRef. ANMDMR: 20412\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSisteme RMN \u2013 Buton \u201dStart Scan\u201d activ \/ manufacturer GE Healthcare (Tianjin) Company Limited, China
\nRef. ANMDMR: 20413\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nIRMA IGF-I \/ manufacturer IMMUNOTECH s.r.o, Cehia
\nRef. ANMDMR: 20426\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nReactiv Inhibin B Gen II \/ manufacturer IMMUNOTECH s.r.o, Cehia
\nRef. ANMDMR: 20429\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nReactiv kit IVD – Banda index A2 \/ manufacturer Devyser AB, Suedia
\nRef. ANMDMR: 20442\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nDeepUnity Viewer \/ manufacturer DH Healthcare GmbH, Germania
\nRef. ANMDMR: 20456\/25<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nCatetere intratecale AscendaTM \/ manufacturer Medtronic Inc., SUA
\nRef. ANMDMR: 20966\/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 \/ MARCH 2025 USER INFORMATION ProPort\u2122 Plastic Implantable Ports \/ manufacturer ICU Medical Inc, SUA […]<\/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-10739","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\/10739","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=10739"}],"version-history":[{"count":3,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/posts\/10739\/revisions"}],"predecessor-version":[{"id":10942,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/posts\/10739\/revisions\/10942"}],"wp:attachment":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/media?parent=10739"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/categories?post=10739"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/tags?post=10739"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}