{"id":11384,"date":"2025-11-24T09:00:21","date_gmt":"2025-11-24T06:00:21","guid":{"rendered":"https:\/\/www.anm.ro\/en\/?p=11384"},"modified":"2025-11-24T14:37:51","modified_gmt":"2025-11-24T11:37:51","slug":"sumarul-notificarilor-in-materie-de-siguranta-in-teren-octombrie-2025","status":"publish","type":"post","link":"https:\/\/www.anm.ro\/en\/sumarul-notificarilor-in-materie-de-siguranta-in-teren-octombrie-2025\/","title":{"rendered":"Summary of field safety notifications \/ OCTOBER 2025"},"content":{"rendered":"

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

PRODUCT RECALL<\/strong>
\nMediloop \/ manufacturer Neuromedex GmbH, Germania
\nRef. ANMDMR: 1323\/25<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nRezerv\u0103 inteligent\u0103 cu v\u00e2rf curbat \u0219i diametru mic Signia\u2122 Covidien\/ manufacturer Covidien LLC, SUA
\nRef. ANMDMR: 1326\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nOrbis Medication 3.x\/manufacturer DH Healthcare GmbH, Germania
\nRef. ANMDMR: 1327\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nCRP FS \/ manufacturer DiaSys Diagnostic Systems GmbH, Germania
\nRef. ANMDMR: 1340\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nCT 5300 \u0219i Incisive CT cu versiunea software V5.1\/manufacturer Philips Healthcare (Suzhou) Co., Ltd, China
\nRef. ANMDMR: 1341\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nStandard dressing forceps\/ manufacturer Tekno-Medical Optik Chirurgie GmbH, Germania
\nRef. ANMDMR: 1353\/25<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nZipTight\u2122 Fixation System for AC Joint Repair \/ manufacturer Biomet Sports Medicine, SUA
\nRef. ANMDMR: 1357\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nDefibrilator extern Reanibex 300\/500 \/ manufacturer Osatu S. Coop., Spania
\nRef. ANMDMR: 1362\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSalem Sump\u2122 Stomach Tubes with Anti-Reflux Valve \/ manufacturer Cardinal Health 200 LLC, SUA
\nRef. ANMDMR: 1364\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nKapillardrain \/ manufacturer Primed Halberstadt Medizintechnik GmbH, Germania
\nRef. ANMDMR: 1368\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nAW Server \/ manufacturer GE Medical Systems SCS, Franta
\nRef. ANMDMR: 1372\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nEllo \/ manufacturer VOSS healthcare GmbH, Germania
\nRef. ANMDMR: 1386\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSekumatic NDT\/ manufacturer Ecolab Deutschland GmbH, Germania
\nRef. ANMDMR: 1388\/25<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nVitus-Fi Distal Fibula Nail \/ manufacturer Dieter Marquardt Medizintechnik GmbH, Germania
\nRef. ANMDMR: 1389\/25<\/p>\n

USER INFORMATION<\/strong>
\nPompe seringi BD Alaris\u2122\/ manufacturer BD Switzerland S\u00e0rl, Elve\u021bia
\nRef. ANMDMR: 1390\/25<\/span><\/a><\/p>\n

USER INFORMATION <\/strong>
\nVentilator BiPAP A40 Pro \/ manufacturer Philips Respironics, Inc., SUA
\nRef. ANMDMR: 1402\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nVaporizator V90 \/ manufacturer Shenzhen Mindray Bio-Medical Electronics Co., Ltd., China
\nRef. ANMDMR: 1406\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nAvanos Introducer Kit for Gastrostomy feeding Tubes\/ manufacturer Avanos Medical Inc, SUA
\nRef. ANMDMR: 1412\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nAlinity hq Analyzer \/ manufacturer Abbott Laboratories, SUA
\nRef. ANMDMR: 1413\/25<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nSingle Use Electrosurgical Snare SD-400 \/ manufacturer Olympus Medical Systems Corporation, Japonia
\nRef. ANMDMR: 1417\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nOlympus duodenoscope \/ manufacturer Olympus Medical Systems Corporation, Japonia
\nRef. ANMDMR: 1420\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nCatalyst+ HD, Catalyst HD \/ manufacturer C-RAD Positioning AB, Suedia
\nRef. ANMDMR: 1422\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSwing-Band\u00ae \/ manufacturer THT Bio-Science, Franta
\nRef. ANMDMR: 1428\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nAzurion 7M20 cu stativ FlexArm \/ manufacturer Philips Medical Systems Nederland BV, Olanda
\nRef. ANMDMR: 1429\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nControlerele de sistem HeartMate II\u00ae \u0219i HeartMate 3\u2122 utilizate cu HeartMate 3\u2122 LVAS \u0219i HeartMate II\u00ae LVAS \/ manufacturer Abbott Medical, SUA
\nRef. ANMDMR: 1430\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nPomp\u0103 de s\u00e2nge CentriMagTM \/manufacturer Abbott Medical, SUA
\nRef. ANMDMR: 1431\/25<\/span><\/a><\/p>\n

USER INFORMATION <\/strong>
\nShockPulse Lithotripsy Transducer \/ manufacturer Gyrus ACMI, Inc. (Olympus Surgical Technologies America), SUA
\nRef. ANMDMR: 1432\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nsisteme de medicin\u0103 nuclear\u0103\/ manufacturer GE medical Systems Israel, Functional Imaging, Israel
\nRef. ANMDMR: 1433\/25<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nCitraLock Syringe 4%\/manufacturer Sterisets Manufacturing S.A, Portugalia
\nRef. ANMDMR: 1434\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nUltramat S \/ manufacturer SDI Limited, Australia
\nRef. ANMDMR: 1437\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nEasy Pulse \/ manufacturer Schiller AG, Elvetia
\nRef. ANMDMR: 1444\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nBio-Rad GenieTM Fast HIV 1\/2 \/ manufacturer Bio-Rad, Franta
\nRef. ANMDMR: 1445\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nGiraffe OmniBed \u0219i Giraffe OmniBed Carestation\/ manufacturer Datex-Ohmeda Inc, SUA
\nRef. ANMDMR: 1453\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nAnalizorul digital automat de morfologie celular\u0103 DI-60 \/ manufacturer CellaVision AB, Suedia
\nRef. ANMDMR: 1454\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nAutocal, Cholesterol Liquicolor \/ manufacturer Human Gesellschaft f\u00fcr Biochemica und Diagnostica mbH, Germania
\nRef. ANMDMR: 1456\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nMonitor de pacient 6500\/ manufacturer Philips Medizin Systeme B\u00f6blingen GmbH, Germania
\nRef. ANMDMR: 1457\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nLiaison\u00ae C. difficile Toxins A&B \/ manufacturer Diasorin Inc, SUA
\nRef. ANMDMR: 1460\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nDigital Radiography System and Ceiling type X-RAY tube support \/ manufacturer Shimadzu Corporation, Japonia
\nRef. ANMDMR: 1470\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSamsung Digital Diagnostic Mobile X-ray System GM85\/ manufacturer Samsung Electronics Co., Limited, Coreea
\nRef. ANMDMR: 1471\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nPakPlus\u00ae \/ manufacturer Immucor GTI Diagnostics (A Werfen Company), SUA
\nRef. ANMDMR: 1472\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nMedap Twista SP, Medap Bora UP, Medap Venta SP \u0219i Atmos Varioair 3 \/ manufacturer ATMOS MedizinTechnik GmbH & Co. KG, Germania
\nRef. ANMDMR: 1479\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nC\u0103rucior FlexTrak reglabil pe \u00een\u0103l\u021bime \/ manufacturer Philips Medical Systems Nederland B.V, Tarile de Jos
\nRef. ANMDMR: 1482\/25<\/p>\n

USER INFORMATION<\/strong>
\nSistem de compresie secven\u021bial\u0103 Kendall SCD\u2122 700, \/ manufacturer Cardinal Health 200, LLC, SUA
\nRef. ANMDMR: 1490\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nAcul hipodermic KD-FINE\u00ae SAFETY \/ manufacturer KD Medical GmbH Hospital Products, Germania
\nRef. ANMDMR: 1491\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nShockPulse Lithotripsy Transducer \/ manufacturer Gyrus ACMI, Inc. (Olympus Surgical Technologies America), SUA
\nRef. ANMDMR: 1492\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nUltramat S \/ manufacturer SDI Limited, Australia
\nRef. ANMDMR: 1493\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nAnalizoarele de imunologie UniCel DxI 600 \u0219i 800 \/ manufacturer Beckman Coulter, Inc., SUA
\nRef. ANMDMR: 1495\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nAutomated Impella Controller (AIC) – AIC Purge Retainer Fixation Correction \/ manufacturer Abiomed Inc., SUA
\nRef. ANMDMR: 1496\/25<\/span><\/a><\/p>\n

USER INFORMATION <\/strong>
\nSetpack\/ Toptex Laparotomy Swabs \/ manufacturer Lohmann & Rauscher International, Germania
\nRef. ANMDMR: 1499\/25<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nZen-O lite\u2122 Portable Oxygen Concentrator \/ manufacturer Gas Control Equipment Ltd, Marea Britanie
\nRef. ANMDMR: 1503\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nMAS\u00ae Omni\u2022CARDIO\u2122 Liquid Assayed Integrated Cardiac Control \/ manufacturer Microgenics Corporation, as part of Thermo Fisher Scientific, SUA
\nRef. ANMDMR: 1516\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nCareLink\u2122 Clinic \/ manufacturer Medtronic MiniMed, SUA
\nRef. ANMDMR: 1517\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nMAC VU360 Acquisition Trunk Cable and Module Holder \/ manufacturer GE Medical Systems Information Technologies, Inc., SUA
\nRef. ANMDMR: 1518\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nELECTROLYTE ANALYZER W\/O STARTERKIT 9180 \/ manufacturer Roche Diagnostics GmbH, Germania
\nRef. ANMDMR: 1519\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nIntranasal Mucosal Atomization Device \/ manufacturer Pulmodyne Inc., SUA
\nRef. ANMDMR: 1523\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nEvis Exera III Colonovideoscope \/ manufacturer Olympus Medical Systems Corporation, Japonia
\nRef. ANMDMR: 1529\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nDr\u00e4ger Catheter Mounts ErgoStar CM 40, ErgoStar CM 45, ErgoStar CM 55, ErgoStar CM 60 \/ manufacturer Dr\u00e4gerwerk AG & Co. KGaA, Germania
\nRef. ANMDMR: 1530\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSistem imagistic\u0103 cu rezonan\u0163\u0103 magnetic\u0103 (IRM) \/ manufacturer Siemens Healthcare GmbH, Germania
\nRef. ANMDMR: 1536\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSistem imagistic\u0103 cu rezonan\u0163\u0103 magnetic\u0103 (IRM) \/ manufacturer Siemens Healthcare GmbH, Germania
\nRef. ANMDMR: 1537\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSLsolution\u2122 \/ manufacturer Copan Italia Spa, Italia
\nRef. ANMDMR: 1546\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSistemele Philips Allura Xper \/ manufacturer Philips Medical Systems Nederland BV, \u021a\u0103rile de Jos
\nRef. ANMDMR: 1547\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nCeiling suspension of Philips Diagnostic X-Ray (DXR) systems\/ manufacturer Philips Medical Systems DMC GmbH, Germania
\nRef. ANMDMR: 1550\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nBiosen Linearity Test Kit \/ manufacturer EKF-diagnostic GmbH, Germania
\nRef. ANMDMR: 1551\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nCelox PPH Uterine Haemostatic Tamponade \/ manufacturer Medtrade Products Ltd, Marea Britanie
\nRef. ANMDMR: 1553\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nBicarbonat \/ manufacturer Beckman Coulter Ireland Inc., Irlanda
\nRef. ANMDMR: 1556\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nBRAF 600\/601 StripAssay \/manufacturer ViennaLab Diagnostics GmbH, Austria
\nRef. ANMDMR: 71048\/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 \/ OCTOBER 2025 PRODUCT RECALL Mediloop \/ manufacturer Neuromedex GmbH, Germania Ref. ANMDMR: 1323\/25 PRODUCT […]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-11384","post","type-post","status-publish","format-standard","hentry","category-uncategorized"],"post_mailing_queue_ids":[],"_links":{"self":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/posts\/11384","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=11384"}],"version-history":[{"count":1,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/posts\/11384\/revisions"}],"predecessor-version":[{"id":11386,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/posts\/11384\/revisions\/11386"}],"wp:attachment":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/media?parent=11384"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/categories?post=11384"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/tags?post=11384"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}