{"id":10414,"date":"2024-10-07T12:53:13","date_gmt":"2024-10-07T09:53:13","guid":{"rendered":"https:\/\/www.anm.ro\/en\/?page_id=10414"},"modified":"2025-08-04T09:54:50","modified_gmt":"2025-08-04T06:54:50","slug":"sumarul-notificarilor-in-materie-de-siguranta-in-teren-august-2024","status":"publish","type":"post","link":"https:\/\/www.anm.ro\/en\/sumarul-notificarilor-in-materie-de-siguranta-in-teren-august-2024\/","title":{"rendered":"Summary of field safety notifications \/ AUGUST 2024"},"content":{"rendered":"

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

USER INFORMATION<\/strong>
\nBiPAP A30, BiPAP A30 EFL, BiPAP A30 Hybrid, BiPAP A40, BiPAP A40 EFL, BiPAP A40 Pro \/ manufacturer Respironics, Inc., SUA
\nRef. NAMMDR: 302.227\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSamsung Digital Diagnostic Mobile X-ray System\/ manufacturer Samsung Electronics Co., Limited, Coreea
\nRef. NAMMDR: 304.345\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nMobileDiagnost wDR \/ manufacturer Philips Medical Systems DMC GmbH, Germania
\nRef. NAMMDR: 304.355\/24<\/p>\n

USER INFORMATION<\/strong>
\nFlow Cytometer \/ manufacturer Sysmex Corporation Japan, Japonia
\nRef. NAMMDR: 304.738\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nHeartStart Intrepid Monitor\/Defibrillator display intermittent ECG waveforms\/ manufacturer Philips Goldway (Shenzhen) Industrial Inc., China
\nRef. NAMMDR: 304.744\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nPST 500 U Precision Surgical Table \/ manufacturer Baxter Medical Systems GmbH + Co. KG, Germania
\nRef. NAMMDR: 304.746\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSistem radiografic de uz general Proteus XR\/a \/ manufacturer GE Hualun Medical Systems Co. Ltd, China
\nRef. NAMMDR: 304.747\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nArm support for display wall suspension – Luminos Agile\/dRF\/Lotus Max, Multitom Rax \/ manufacturer Siemens Healthcare GmbH, Germania
\nRef. NAMMDR: 304.748\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nIncorrect Software Options for Philips lntelliVue Patient Monitors MX400\/450\/500\/550 \/ manufacturer Philips Medizin Systeme B\u00f6blingen GmbH, Germania
\nRef. NAMMDR: 304.750\/24<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nWallFlexTM – Sistem de stent esofagian, AgileTM – Sistem de stent esofagian cu fir \/ manufacturer Boston Scientific Corporation, SUA
\nRef. NAMMDR: 304.751\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSpaceplus Infusomat\u00ae – Wave Spring \/ manufacturer B.Braun Melsungen AG, Germania
\nRef. NAMMDR: 304.858\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nPapenzyme Plus \/ manufacturer Lorne Laboratories Ltd., Marea Britanie
\nRef. NAMMDR: 304.859\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nMonitorul\/defibrilatorul HeartStart Intrepid – Forma de und\u0103 EKG intermitente \/ manufacturer Philips Goldway (Shenzhen) Industrial Inc., China
\nRef. NAMMDR: 304.872\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nMulti-Socket Strip \/ manufacturer MTG Medizinisch-Technische Ger\u00e4tebau GmbH, Germania
\nRef. NAMMDR: 304.899\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nOlympus EndoDis Pro \/ manufacturer Ecolab Deutschland GmbH, Germania
\nRef. NAMMDR: 304.900\/24<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nRite Aid Hydrogel Breast Discs 12pk \/ manufacturer ToLife Technologies Pty Ltd, Australia
\nRef. NAMMDR: 304.901\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nDental drill \/ manufacturer Acurata GmbH & Co. KGaA, Germania
\nRef. NAMMDR: 304.907\/24<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nMONOPLUS\u00ae, MONOSYN\u00ae, NOVOSYN\u00ae, NOVOSYN\u00ae CHD \/ manufacturer B. Braun Surgical, S.A., Spania
\nRef. NAMMDR: 304.908\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\n Ventilatoare LUISA, TIVAN LS, Life One\/ manufacturer L\u00f6wenstein Medical Technology GmbH + Co. KG, Germania
\nRef. NAMMDR: 304.909\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nAlinity hq Analyzer \/ manufacturer Abbott Laboratories, SUA
\nRef. NAMMDR: 304.910\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nAparate de anestezie – Aisys CS2, Avance CS2, Avance CS2 Pro, Aisys, Avance, Amingo, Aespire 100, Aespire View, Aespire 7900 \u0219i Aespire 7100 configurate cu ie\u0219ire de gaz comun\u0103 auxiliar\u0103 \/ manufacturer Datex-Ohmeda, Inc., SUA
\nRef. NAMMDR: 304.980\/24<\/span><\/a><\/p>\n

USER INFORMATION\/ PRODUCT RECALL<\/strong>
\nLentile de contact Alcon DAILIES TOTAL1\u00ae \u0219i TOTAL30\u00ae \/ manufacturer Alcon Laboratories, Inc., SUA
\nRef. NAMMDR: 304.988\/24<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nForehead Reamer \/ manufacturer Unintech GmbH, Germania
\nRef. NAMMDR: 304.989\/24<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nCustom Tubing Packs (CTP) \/ manufacturer Maquet Cardiopulmonary GmbH, Germania
\nRef. NAMMDR: 305.054\/24<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nSalivary Testosterone ELISA \/ manufacturer DRG Instruments GmbH, Germania
\nRef. NAMMDR: 305.055\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nHD Lightweight Pendulum Camera Head \/ manufacturer Olympus Medical Systems Corporation, Japonia
\nRef. NAMMDR: 305.056\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSistemul Philips Azurion R1.x \/ manufacturer Philips Medical Systems Nederland BV, Olanda
\nRef. NAMMDR: 305.058\/24<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\n1.2 K-Wire, Lancet, 150mm \/ manufacturer Medartis AG, Elve\u021bia
\nRef. NAMMDR: 305.060\/24<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nREGENETEN Tendon Anchors \/ manufacturer Smith & Nephew, Inc., SUA
\nRef. NAMMDR: 305.106\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nVENTANA anti-CD10 (SP67) Rabbit Monoclonal Primary Antibody \/ manufacturer Ventana Medical Systems Inc, SUA
\nRef. NAMMDR: 305.107\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nHigh flow insufflation unit \/ manufacturer Olympus Medical Systems Corporation, Japonia
\nRef. NAMMDR: 305.110\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nORBIS Medication 3.x \/ manufacturer DH Healthcare GmbH, Germania
\nRef. NAMMDR: 305.116\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSerial interface cable (RS232) for Rotaflow II System \/ manufacturer Maquet Cardiopulmonary GmbH, Germania
\nRef. NAMMDR: 305.117\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nMarodyne-LiV \/ manufacturer BTT Health GmbH, Germania
\nRef. NAMMDR: 305.124\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\n Fluido\u00ae Trauma set 671500\/ Fluido\u00ae Standard set 671200 \/ manufacturer The Surgical Company International BV
\nRef. NAMMDR: 305.126\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nHeart pump : Impella 5.5 with SmartAssist and Impella CP with SmartAssist \/ manufacturer Abiomed Inc., SUA
\nRef. NAMMDR: 305.128\/24<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nMulticath2 \/ manufacturer VYGON GmbH & Co. KG, Germania
\nRef. NAMMDR: 305.226\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nDeepUnity Diagnost (all versions) \/ manufacturer DH Healthcare GmbH, Germania
\nRef. NAMMDR: 305.228\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nDeepUnity Viewer (all versions) \/ manufacturer DH Healthcare GmbH, Germania
\nRef. NAMMDR: 305.229\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nVanta\u2122 Implantable Neurostimulator \/ manufacturer Medtronic Inc., SUA
\nRef. NAMMDR: 305.231\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nBattery corpuls cpr (LiPo) \/ manufacturer GS Elektromedizinische Ger\u00e4te G. Stemple GmbH, Germania
\nRef. NAMMDR: 305.232\/24<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nHLM Tubing Set \/ manufacturer Maquet Cardiopulmonary GmbH, Germania
\nRef. NAMMDR: 305.234\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nAzurion 7M20 cu stativ FlexArm \/ manufacturer Philips Medical Systems Nederland BV, Olanda
\nRef. NAMMDR: 305.264\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nTrilogy Evo, Trilogy Evo O2 \u015fi Trilogy EV300 \/ manufacturer Philips Respironics, Inc., SUA
\nRef. NAMMDR: 305.265\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nActualizare software – StealthStation\u2122 S8 \/ manufacturer Medtronic Navigation Inc., SUA
\nRef. NAMMDR: 305.320\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nAlinity i HBsAg Controls, ARCHITECT HBsAg Controls \/ manufacturer Abbott Ireland Diagnostics Division, Irlanda
\nRef. NAMMDR: 305.321\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nOrtho DataVue System \/ manufacturer BECOM Software AG, Germania
\nRef. NAMMDR: 305.326\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nVentilatoare Sophie \u0219i Sophie 2020\/ manufacturer Fritz Stephan GmbH, Germania
\nRef. NAMMDR: 305.329\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nHus\u0103 deta\u0219abil\u0103 de recuperare Endo \/ manufacturer Unimax Medical Systems, Inc., Taiwan
\nRef. NAMMDR: 305.385\/24<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nAnalizoare ACL TOP Family \u0219i ACL TOP Family Seria 50 \/ manufacturer Instrumentation laboratory Co., SUA
\nRef. NAMMDR: 306.020\/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 \/ AUGUST 2024 USER INFORMATION BiPAP A30, BiPAP A30 EFL, BiPAP A30 Hybrid, BiPAP A40, […]<\/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-10414","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\/10414","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=10414"}],"version-history":[{"count":4,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/posts\/10414\/revisions"}],"predecessor-version":[{"id":10422,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/posts\/10414\/revisions\/10422"}],"wp:attachment":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/media?parent=10414"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/categories?post=10414"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/tags?post=10414"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}