{"id":10425,"date":"2024-10-07T16:01:24","date_gmt":"2024-10-07T13:01:24","guid":{"rendered":"https:\/\/www.anm.ro\/en\/?page_id=10425"},"modified":"2025-08-04T09:54:42","modified_gmt":"2025-08-04T06:54:42","slug":"sumarul-notificarilor-in-materie-de-siguranta-in-teren-iulie-2024","status":"publish","type":"post","link":"https:\/\/www.anm.ro\/en\/sumarul-notificarilor-in-materie-de-siguranta-in-teren-iulie-2024\/","title":{"rendered":"Summary of field safety notifications \/ JULY 2024"},"content":{"rendered":"

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

USER INFORMATION<\/strong>
\nfabian\u2122 HFO \/ manufacturer Acutronic Medical Systems AG, Elve\u021bia
\nRef. ANMDMR: 302.584\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nHorizon X-Ray Bone Densitometer (DXA) \/ manufacturer Hologic, Inc., SUA
\nRef. ANMDMR: 303.758\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nLDH-P, opt. DGKC \/ manufacturer DIALAB \u2013 Produktion und Vertrieb von chemisch-technischen Produkten und Laborinstrumenten Gesellschaft m.b.H., Austria
\nRef. ANMDMR: 303.866\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nPapaina \/ manufacturer DIALAB \u2013 Produktion und Vertrieb von chemisch-technischen Produkten und Laborinstrumenten Gesellschaft m.b.H., Austria
\nRef. ANMDMR: 303.905\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nCPT\u00ae Hip System Femoral Stem 12\/14 Neck Taper \/ manufacturer Zimmer Inc., SUA
\nRef. ANMDMR: 304.122\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSistemul FILMARRAY TORCH \/ manufacturer BioFire Diagnostics, LLC, SUA
\nRef. ANMDMR: 304.124\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nBobine SENSE XL Torso (1.5T \u015fi 3.0T) \/ manufacturer Philips Healthcare, Olanda
\nRef. ANMDMR: 304.125\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nPST 500 Precision Surgical Table \/ manufacturer Baxter Medical Systems GmbH +Co. KG, Germania
\nRef. ANMDMR: 304.133\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nVentana anti-CD10 (SP67) Rabbit Monoclonal Primary Antibody \/ manufacturer Ventana Medical Systems Inc., SUA
\nRef. ANMDMR: 304.158\/24<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nBioPince\u2122, BioPinceUltra\u2122 and TruCore\u2122 II Automatic Biopsy Instruments \/ manufacturer Argon Medical Devices, Inc., SUA
\nRef. ANMDMR: 304.160\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nAlinity c Proteins Standard \/ manufacturer Biokit S.A, Spania
\nRef. ANMDMR: 304.164\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nDeepUnity Viewer \/ manufacturer DH Healthcare GmbH, Germania
\nRef. ANMDMR: 304.167\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nOncomine\u00ae Dx Express Test Panel \/ manufacturer Life Technologies Corporation, SUA
\nRef. ANMDMR: 304.168\/24<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nWound dressing epicite hydro \/ manufacturer JeNaCell GmbH, Germania
\nRef. ANMDMR: 304.285\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nProvo.X \/ manufacturer Ganshorn Medizin Electronic GmbH, Germania
\nRef. ANMDMR: 304.324\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nCursor autonom programator Medtronic CareLink\u2122 2090 \/ manufacturer Medtronic Inc., SUA
\nRef. ANMDMR: 304.325\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nComutator manual Ziehm #88036 pentru Ziehm 8000, Ziehm Solo, Ziehm Solo FD, Ziehm Vision, Ziehm Vision FD, Ziehm Vision R, Ziehm Vision RFD, Ziehm Vision RFD 3D \/ manufacturer Ziehm Imaging GmbH, Germania
\nRef. ANMDMR: 304.327\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nHandbike Infinity \/ manufacturer Decon Wheel AB., Suedia
\nRef. ANMDMR: 304.330\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nPrucka 3 Amplifiers used with CardioLab and ComboLab systems \/ manufacturer GE Medical Systems Information Technologies, Inc., SUA
\nRef. ANMDMR: 304.332\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nAccu-Chek\u00ae Guide system\/ manufacturer Roche Diabetes Care GmbH, Germania
\nRef. ANMDMR: 304.333\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nBeneHeart C Series \/ manufacturer Shenzhen Mindray Bio-Medical Electronics Co., Ltd., China
\nRef. ANMDMR: 304.334\/24<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nMEGADYNE\u2122 MEGA SOFT\u2122 Pediatric Patient Return Electrode \/ manufacturer Megadyne Medical Products, Inc, SUA
\nRef. ANMDMR: 304.357\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nDefective hand switches on mobile X-ray devices\/ manufacturer Ziehm Imaging GmbH, Germania
\nRef. ANMDMR: 304.358\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nVarioXX\u00b2 wheelchair \/ manufacturer novacare\u00ae gmbh, Germania
\nRef. ANMDMR: 304.359\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nOlympus EndoDis Pro \/ manufacturer Ecolab Deutschland GmbH, Germania
\nRef. ANMDMR: 304.360\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nORBIS Medication 03.19.x \/ manufacturer DH Healthcare GmbH, Germania
\nRef. ANMDMR: 304.361\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nWireless Footswitch \/ manufacturer Gyrus ACMI, Inc. (Olympus Surgical Technologies America), SUA
\nRef. ANMDMR: 304.362\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nUMIC Colistin \/ manufacturer Bruker Daltonics GmbH & Co. KG, Germania
\nRef. ANMDMR: 304.412\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nNADAL\u00ae Troponin I Test \/ manufacturer nal von minden GmbH, Germania
\nRef. ANMDMR: 304.417\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nLaryngoscope LED handles, green system (reusable) \/ manufacturer Starkling e.K., Germania
\nRef. ANMDMR: 304.430\/24<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nVENUS implant systems \/ manufacturer HumanTech Spine GmbH, Germania
\nRef. ANMDMR: 304.445\/24<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nProducts containing the component vacuum-tight reservoir VHK 71000\/ manufacturer Maquet Cardiopulmonary GmbH, Germania
\nRef. ANMDMR: 304.448\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nReplacing the power supply unit for care beds in the Ecofit range \/ manufacturer tecfor care GmbH, Germania
\nRef. ANMDMR: 304.454\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nShimadzu CVS system – Trinias\/ manufacturer Shimadzu Corporation, Japonia
\nRef. ANMDMR: 304.455\/24<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nPeripheral support catheter iVascular sergeant 18 \/ manufacturer Life Vascular Devices Biotech, S.L., Spania
\nRef. ANMDMR: 304.479\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\ncorPatch easy, corPatch easy pre-connected, corPatch easy pediatric \/ manufacturer Leonhard Lang GmbH, Austria
\nRef. ANMDMR: 304.482\/24<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\n medical compression stockings and supports \/ manufacturer Bauerfeind AG, Germania
\nRef. ANMDMR: 304.486\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nTuburi de ventila\u021bie auricular\u0103 \/ manufacturer Exmoor Plastics Limited, Marea Britanie
\nRef. ANMDMR: 304.487\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nkit BD BACTEC\u2122 MGIT\u2122 960 PZA \/ manufacturer Becton Dickinson and Company
\nRef. ANMDMR: 304.514\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nVentilator BiPAP A40 Pro, ventilator BiPAP A40 EFL \u015fi ventilator BiPAP A30 EFL\/ manufacturer Philips Respironics, Inc., SUA
\nRef. ANMDMR: 304.533\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nReplacing the power supply unit for care beds in the Ecofit Xtra range\/ manufacturer tecfor care GmbH, Germania
\nRef. ANMDMR: 304.537\/24<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nFiberTak\u2122 Suture Anchor with #2 FiberWire\u00ae CL, FiberTak\u2122 Suture Anchor, Double Loaded with 1.3 mm SutureTape\u2122, FiberTak\u2122 Suture Anchor, Double Loaded with 1.3 mm SutureTape\u2122, FiberTak\u2122 Suture Anchor #2 FiberWire\u00ae CL \/ manufacturer Arthrex GmbH; Germania
\nRef. ANMDMR: 304.539\/24<\/span><\/a><\/p>\n

USER INFORMATION
\nPhilips Interventional HemodynaFmic System \u2013 IntelliVue X3 \/ manufacturer Philips Medizin Systeme B\u00f6blingen GmbH, Germania
\nRef. ANMDMR: 304.540\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nElectrosurgical Generator \/ manufacturer Olympus Winter & Ibe GmbH, Germania
\nRef. ANMDMR: 304.589\/24<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nDr\u00e4ger Alcotest 7000 charging cradle (3700420) \/ manufacturer Dr\u00e4ger Safety AG & Co. KGaA, Germania
\nRef. ANMDMR: 304.590\/24<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nEasyConnect\u2122 Adapter for 2 to 4 Lumen Jet Catheter\/ manufacturer Carl Reiner GmbH, Germania
\nRef. ANMDMR: 304.718\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nHolotype HLA assay kit configurations \/ manufacturer Omixon Biocomputing Ltd, Ungaria
\nRef. ANMDMR: 304.753\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nS-Monovette\u00ae Lithium heparin LH, 4,9 ml \/ manufacturer Sarstedt AG&Co.KG, Germania
\nRef. ANMDMR: 304.755\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nALFA-Flex, BETA-Flex \/ manufacturer Semeda GmbH, Germania
\nRef. ANMDMR: 304.784\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nIRISpec CA\/CB\/CC \/ manufacturer Beckman Coulter Ireland, Inc., Irlanda
\nRef. ANMDMR: 304.790\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nIRISpec CA\/CB\/CC \/ manufacturer Beckman Coulter Ireland, Inc., Irlanda
\nRef. ANMDMR: 304.793\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nGPT (ALT), mod. IFCC \/ manufacturer DIALAB – Produktion und Vertrieb von chemisch-technischen Produkten und Laborinstrumenten Gesellschaft m.b.H., Austria
\nRef. ANMDMR: 304.795\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nMEGADYNE\u2122 MEGA SOFT\u2122 and MEGA 2000\u2122 Reusable Patient Return Electrodes \/ manufacturer Megadyne Medical Products, Inc., SUA
\nRef. ANMDMR: 304.798\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nPiccolo\u00ae General Chemistry 13 \/ manufacturer Abaxis Inc., SUA
\nRef. ANMDMR: 304.799\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nVentilatoare LUISA, TIVAN LS, Life One \/ manufacturer L\u00f6wenstein Medical Technology GmbH + Co. KG, Germania
\nRef. ANMDMR: 304.801\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nOperator\u2019s Guide & Quick Reference Guide for ZOLL MRI Compatible Ventilator \/ manufacturer ZOll Medical Corporation, SUA
\nRef. ANMDMR: 304.804\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nInstrumente BD Phoenix\u2122 M50 \u0219i BD Phoenix\u2122 100 \/ manufacturer Becton Dickinson and Company, SUA
\nRef. ANMDMR: 304.812\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSursa de alimentare a display-ului tactil pentru sistemele AXIOM MULTIX MT, AXIOM MULTIX MP, AXIOM Vertix MD, AXIOM Vertix Solitaire, MULTIX Swing, MULTIX TOP \/ manufacturer Siemens Healthcare GmbH, Germania
\nRef. ANMDMR: 304.813\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nExoplan – Matera, Galway, Rijeka \/ manufacturer exocad GmbH, Germania
\nRef. ANMDMR: 304.814\/24<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nAsqelio\u2122 Preloaded IOL Delivery System \/ manufacturer AST Products, Inc., SUA
\nRef. ANMDMR: 304.815\/24<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nLentile intraoculare CT LUCIA 221P 23.0D & 28.5D \/ manufacturer Carl Zeiss Meditec AG (CZM AG), Germania
\nRef. ANMDMR: 304.816\/24<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nRCM6\u00ae Resorbable Collagen Membrane 30MM x 40MM \/ manufacturer Collagen Matrix, Inc, SUA
\nRef. ANMDMR: 304.818\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nTempus LS \/ manufacturer SCHILLER AG, Elevetia
\nRef. ANMDMR: 304.823\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nTrephine Blades \/ manufacturer MicroSurgical Technology Inc., SUA
\nRef. ANMDMR: 304.826\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nJuvelook \/ manufacturer VAIM Co., Ltd., Coreea
\nRef. ANMDMR: 304.831\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nEndoPredict QS Kit UNO & EndoPredict QS Kit DUO\/ manufacturer Myriad International GmbH, Germania
\nRef. ANMDMR: 304.835\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nORBIS Medication 03.X\/ manufacturer DH Healthcare GmbH, Germania
\nRef. ANMDMR: 304.836\/24<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nZementieradapter mit St\u00f6\u00dfel XL \/ manufacturer Peter Brehm GmbH, Germania
\nRef. ANMDMR: 304.838\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nCARDIOVIT AT-180 \/ manufacturer SCHILLER AG, Elvetia
\nRef. ANMDMR: 304.839\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nmySugr Bolus Calculator \/ manufacturer mySugr GmbH, Austria
\nRef. ANMDMR: 304.840\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nShimadzu Digital Angiography System:Trinias \/ manufacturer SHIMADZU Corporation, Japonia
\nRef. ANMDMR: 304.841\/24<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nOlympus Everest Bipolar Cutting Forceps \/ manufacturer Olympus Surgical Technologies, SUA
\nRef. ANMDMR: 304.842\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nCorneal Irrigator \/ manufacturer Bausch & Lomb GmbH, Germania
\nRef. ANMDMR: 304.843\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSpiegelberg Silverline\u00ae ventricular catheter 8F \/ manufacturer Spiegelberg GmbH & Co.KG, Germania
\nRef. ANMDMR: 304.845\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nOlympus EndoDis Pro \/ manufacturer Ecolab Deutschland GmbH, Germania
\nRef. ANMDMR: 304.849\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nHyalobarrier\u00ae Gel Endo 3 Pack, Hyalobarrier Gel \/ manufacturer Anika Therapeutics S.r.l., Italia
\nRef. ANMDMR: 304.860\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSistem de gestionare a temperaturii Arctic Sun\u2122 5000 \/ manufacturer Medivance, Inc., SUA
\nRef. ANMDMR: 305.059\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nKit implant HeartMate 3\u2122 LVAS, Controller sistem HeartMate 3\u2122 LVAS, Controller sistem HeartMate 3TM Low Flow \/ manufacturer Abbott Medical, SUA
\nRef. ANMDMR: 305.083\/24<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nHPS 2.0 Rod coupler, S=25N\/mm, 27mm \/ manufacturer Paradigm Spine GmbH, Germania
\nRef. ANMDMR: 305.123\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nlentilele intraoculare :Aspira-Aa(Safeloader), Aspira-aAY (Safeloader), Diff-aA (Safeloader), Diff-aAY (Safeloader), ToricaDiff-aA (Safeloader), ToricaDiff-aAY (Safeloader), Aspira-aXAY (Safeloader), Aspira-aXA (Safeloader), Triva-aA (Safeloader), Triva-aAY (Safeloader), Triva-aXAY (Safeloader),
\nTrivaT-aAY (Safeloader) \/ manufacturer HumanOptics Holding AG, Germania
\nRef. ANMDMR: 305.132\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nReactiv Access HBc Ab \/ manufacturer Beckman Coulter, SUA
\nRef. ANMDMR: 305.149\/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 \/ JULY 2024 USER INFORMATION fabian\u2122 HFO \/ manufacturer Acutronic Medical Systems AG, Elve\u021bia Ref. […]<\/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-10425","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\/10425","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=10425"}],"version-history":[{"count":3,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/posts\/10425\/revisions"}],"predecessor-version":[{"id":10444,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/posts\/10425\/revisions\/10444"}],"wp:attachment":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/media?parent=10425"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/categories?post=10425"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/tags?post=10425"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}