{"id":10890,"date":"2025-07-02T08:00:44","date_gmt":"2025-07-02T05:00:44","guid":{"rendered":"https:\/\/www.anm.ro\/en\/?page_id=10890"},"modified":"2025-08-04T09:01:04","modified_gmt":"2025-08-04T06:01:04","slug":"sumarul-notificarilor-in-materie-de-siguranta-in-teren-mai-2025","status":"publish","type":"post","link":"https:\/\/www.anm.ro\/en\/sumarul-notificarilor-in-materie-de-siguranta-in-teren-mai-2025\/","title":{"rendered":"Summary of field safety notifications \/ MAY 2025"},"content":{"rendered":"

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

USER INFORMATION<\/strong>
\nReactiv pentru creatinin\u0103 \/ manufacturer Beckman Coulter Inc., SUA
\nRef. ANMDMR: 285\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nOlympic Brainz Monitor (DAB)\/ manufacturer Natus Medical Incorporated DBA Excel -Tech Ltd. (XLTEK), Canada
\nRef. ANMDMR: 341\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nCentricity High Acuity Critical Care \u0219i Centricity High Acuity Anesthesia \/ manufacturer GE Healthcare Finland Oy, Finlanda
\nRef. ANMDMR: 345\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSoltive\u2122 SuperPulsed Laser System \/ manufacturer Gyrus ACMI, Inc. (Olympus Surgical Technologies America), SUA
\nRef. ANMDMR: 346\/25<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nB. subtilis inhibitor plate MiQ \/ manufacturer Axon Biotech GmbH, Germania
\nRef. ANMDMR: 350\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nInstinct Plus Endoscopic Clipping Device \/ manufacturer Cook Endoscopy\/Wilson Cook Medical, Inc., SUA
\nRef. ANMDMR: 359\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\n3M\u2122 Ranger\u2122 Blood\/Fluid Warming High Flow Sets \/ manufacturer 3M Company, SUA
\nRef. ANMDMR: 363\/25<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nVentilatoare Leoni plus Transport \/ manufacturer L\u00f6wenstein Medical SE & Co. KG, Germania
\nRef. ANMDMR: 364\/25<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nRinger B. Braun \/ manufacturer B.Braun Melsungen AG, Germania
\nRef. ANMDMR: 365\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nDuodenoscop \/ manufacturer Olympus Medical Systems Corporation, Japonia
\nRef. ANMDMR: 369\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSilverlineR ventricle probe with Cranial Bolt \/ manufacturer Spiegelberg GmbH & Co.KG, Germania
\nRef. ANMDMR: 371\/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

PRODUCT RECALL<\/strong>
\nOptima Coil System \/ manufacturer Balt USA LLC, SUA
\nRef. ANMDMR: 382\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nBX2 Needle Guide \/ manufacturer CIVCO Medical Instruments Co., Inc. d\/b\/a CIVCO Medical Solutions, SUA
\nRef. ANMDMR: 386\/25<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nU-Pette\u00ae, C-Pette\u00ae, H-Pette\u00ae \/ manufacturer Labcon, SUA
\nRef. ANMDMR: 388\/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: 391\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nAniosyme Prime, Aniosyme Synergy 5, Aniospray Quick, Anios Quick Wipes \/ manufacturer Laboratoires Anios, Franta
\nRef. ANMDMR: 392\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSisteme tratare ap\u0103: RO Medical \u0219i RO Medical Basic\/ manufacturer Nipro Pure Water GmbH, Germania
\nRef. ANMDMR: 393\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nAnalizoare de biochimie clinic\u0103 AU480 \u0219i AU680 \/ manufacturer Beckman Coulter, Inc.
\nRef. ANMDMR: 396\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSoltive Laser System \/ manufacturer Gyrus ACMI, Inc. (Olympus Surgical Technologies America), SUA
\nRef. ANMDMR: 397\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nVentilator WEINMANN MEDUMAT Standard\u00b2 \/ manufacturer WEINMANN Emergency Medical Technology GmbH + Co. KG, Germania
\nRef. ANMDMR: 403\/25<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nCarpoFit\u00ae monoblock broach \/ manufacturer implantcast GmbH, Germania
\nRef. ANMDMR: 405\/25<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nEpicutaneo cava \/ manufacturer VYGON Germany GmbH, Germania
\nRef. ANMDMR: 406\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nDexcom Non-Touchscreen Receiver \/ manufacturer Dexcom, Inc. SUA
\nRef. ANMDMR: 411\/25<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nImpactor, iliac peg – MRS-TITAN Maximum \/ manufacturer Peter Brehm GmbH, Germania
\nRef. ANMDMR: 412\/25<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nSet stent ureteral moale\/ferm Universa\u00ae \/ manufacturer Cook Ireland Ltd, Irlanda
\nRef. ANMDMR: 413\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSisteme Centricity High Acuity Critical Care \u0219i Centricity High Acuity Anesthesia \/ manufacturer GE Healthcare Finland Oy, Finlanda
\nRef. ANMDMR: 417\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSisteme Centricity High Acuity Critical Care \u0219i Centricity High Acuity Anesthesia \/ manufacturer GE Healthcare Finland Oy
\nRef. ANMDMR: 418\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSisteme RM cu versiunile SW R11.1 \u0219i R12.1 \/ manufacturer Philips Medical Systems Nederland B.V., Olanda
\nRef. ANMDMR: 419\/25<\/p>\n

USER INFORMATION<\/strong>
\nKit BD BACTEC\u2122 MGIT\u2122 960 PZA \/ manufacturer Becton Dickinson and Company, SUA
\nRef. ANMDMR: 427\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nFRED easyport \/ manufacturer SCHILLER AG, Elvetia
\nRef. ANMDMR: 436\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\n N LATEX FLC LAMBDA\/ manufacturer Siemens Healthcare Diagnostics Products GmbH, Germania
\nRef. ANMDMR: 439\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nAnti TPO Ab ELISA\/ manufacturer DRG Instruments GmbH, Germania
\nRef. ANMDMR: 440\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nCateter IV ecranat BD\u00ae Insyte\u2122 Autoguard\u2122 \/ manufacturer Becton Dickinson Infusion Therapy Systems Inc., SUA
\nRef. ANMDMR: 441\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nAparat de cur\u0103\u021bat cu ultrasunete pentru r\u0103ni – Curason \/ manufacturer Curasonix GmbH, Germania
\nRef. ANMDMR: 446\/25<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nVentilatoare : Newport\u2122 HT70 \u0219i HT70 Plus \/ manufacturer Covidien LLC, SUA
\nRef. ANMDMR: 450\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nConsumabile MEDTRON AG \/ manufacturer MEDTRON AG, Germania
\nRef. ANMDMR: 458\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSistem MUSE 5 \/ manufacturer GE Medical Systems Information Technologies, Inc., SUA
\nRef. ANMDMR: 459\/25<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nExtended Tip Applicator (XTA) \/ manufacturer Integra Lifesciences Corporation, SUA
\nRef. ANMDMR: 463\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nAllon\u00ae \/ manufacturer Belmont Medical Technologies, SUA
\nRef. ANMDMR: 468\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nAlinity i Total PSA Reagent Kit \/ manufacturer Abbott Ireland Diagnostics Division, Irlanda
\nRef. ANMDMR: 471\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nORBIS Medication 3.x \/ manufacturer DH Healthcare GmbH, Germania
\nRef. ANMDMR: 472\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nORBIS Medication 3.x \/ manufacturer DH Healthcare GmbH, Germania
\nRef. ANMDMR: 473\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nMUTARS\u00ae \/ manufacturer implantcast GmbH, Germania
\nRef. ANMDMR: 475\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nMasti oronazale NovaStar plus \u0219i Nova Star TS \/ manufacturer Dr\u00e4gerwerk AG & Co. KGaA, Germania
\nRef. ANMDMR: 490\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSisteme Philips Allura \u0219i Azurion \/ manufacturer Philips Medical Systems Nederland BV, T\u0103rile de Jos
\nRef. ANMDMR: 494\/25<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nLIFEPEARL\u2122 Drug Elutable Microspheres \/ manufacturer MicroVention Europe SARL, Fran\u021ba
\nRef. ANMDMR: 495\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nThyreoidal Peroxidase-Ab (TPO-Ab) \/ manufacturer Demeditec Diagnostics GmbH, Germania
\nRef. ANMDMR: 498\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nDexcom ONE+ iOS CGM App \/ manufacturer Dexcom, Inc., SUA
\nRef. ANMDMR: 500\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nVITROS\u00ae 4600 Chemistry Systems \u0219i VITROS\u00ae 5600 and XT 7600 Integrated Systems \/ manufacturer QuidelOrtho (Ortho Clinical Diagnostics Inc), SUA
\nRef. ANMDMR: 501\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\n428c \/ manufacturer
\nRef. ANMDMR: 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 \/ MAY 2025 USER INFORMATION Reactiv pentru creatinin\u0103 \/ manufacturer Beckman Coulter Inc., SUA 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-10890","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\/10890","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=10890"}],"version-history":[{"count":4,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/posts\/10890\/revisions"}],"predecessor-version":[{"id":10918,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/posts\/10890\/revisions\/10918"}],"wp:attachment":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/media?parent=10890"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/categories?post=10890"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/tags?post=10890"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}