{"id":12105,"date":"2026-05-05T08:00:41","date_gmt":"2026-05-05T05:00:41","guid":{"rendered":"https:\/\/www.anm.ro\/en\/?p=12105"},"modified":"2026-05-05T09:24:09","modified_gmt":"2026-05-05T06:24:09","slug":"sumarul-notificarilor-in-materie-de-siguranta-in-teren-martie-2026","status":"publish","type":"post","link":"https:\/\/www.anm.ro\/en\/sumarul-notificarilor-in-materie-de-siguranta-in-teren-martie-2026\/","title":{"rendered":"Summary of field safety notifications \/ MARCH 2026"},"content":{"rendered":"

SUMMARY OF FIELD SAFETY NOTIFICATIONS \/ MARCH 2026<\/strong><\/p>\n

USER INFORMATION<\/strong>
\nMonitoare pacient Philips IntelliVue\/ manufacturer Philips Medizin Systeme B\u00f6blingen GmbH, Germania
\nRef. ANMDMR: 52\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nLampa chirurgical\u0103 Merivaara Q-Flow \/ manufacturer Merivaara Corporation, Finlanda
\nRef. ANMDMR: 216\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSet de perfuzie \/manufacturer Mentor, SUA
\nRef. ANMDMR: 483\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nDefec\u021biuni ale cablurilor segmentare la pensa Tenaculum \u0219i instrumentul Small GraptorTM de la da Vinci X, da Vinci Xi \u0219i dV5 \/ manufacturer Intuitive Surgical, Inc., SUA
\nRef. ANMDMR: 485\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nDiplomat Screwdriver, set screw \/ manufacturer SIGNUS Medizintechnik GmbH, Germania
\nRef. ANMDMR: 531\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSistemele Philips Azurion \u0219i Allura \/ manufacturer Philips Medical Systems Nederland BV, Tarile de Jos
\nRef. ANMDMR: 543\/26<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nElectrozi defibrilare \/ manufacturer Medical (Physio-Control Inc), SUA
\nRef. ANMDMR: 546\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nImpella RP \/ manufacturer Abiomed Inc., SUA
\nRef. ANMDMR: 550\/26<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nSet electrozi ECG Radius VSM \/ manufacturer Masimo Corporation, SUA
\nRef. ANMDMR: 563\/26<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nOlympus PK\/PKS\/Everest Cutting Forceps \/ manufacturer Gyrus ACMI, Inc. (Olympus Surgical Technologies America), SUA
\nRef. ANMDMR: 566\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nNavitian \/ manufacturer Life Vascular Devices Biotech, S.L., Spania
\nRef. ANMDMR: 579\/26<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nDispozitiv Obturator Diaphysaire Airplug \/ manufacturer Groupe Lepine, Franta
\nRef. ANMDMR: 582\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nAnti IgM PER \/ manufacturer SEBIA, Franta
\nRef. ANMDMR: 583\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSistem Olympus Soltive\u2122 SuperPulsed \/ manufacturer Gyrus ACMI, Inc. (Olympus Surgical Technologies America), SUA
\nRef. ANMDMR: 587\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nCablu de \u00eenalt\u0103 frecven\u0163\u0103 bipolar \/ manufacturer Olympus Winter & Ibe GmbH, Germania
\nRef. ANMDMR: 588\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nFlexible Cryoprobe \/ manufacturer Erbe Elektromedizin GmbH, Germania
\nRef. ANMDMR: 594\/26<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nPiese de m\u00e2n\u0103 marFocus \u0219i marScan \/ manufacturer KLS Martin SE & Co. KG, Germania
\nRef. ANMDMR: 599\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nThoraflex Hybrid\/ manufacturer Vascutek Ltd., Marea Britanie
\nRef. ANMDMR: 605\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nCorec\u021bia Brady SMR6 pentru familia ACCOLADE\u2122 \u0219i extinderea popula\u021biei pentru DR-EL \u0219i CRT-P \/ manufacturer Cardiac Pacemaker Inc \u2013 A wholly owned subsidiary of Guidant Corporation \u2013 A wholly owned subsidiary of Boston Scientific Corporation, SUA
\nRef. ANMDMR: 615\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nResuscitatoare BVM \/ manufacturer Intersurgical Ltd., UK
\nRef. ANMDMR: 619\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nRehabuggy Multiroller \/ manufacturer RehaNorm GmbH & Co. KG, Germania
\nRef. ANMDMR: 628\/26<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nSistem EndoZip \/ manufacturer Nitinotes LTD, Germania
\nRef. ANMDMR: 630\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSpace\u00aeplus Perfusor\u00ae \/ manufacturer B.Braun Melsungen AG, Germania
\nRef. ANMDMR: 637\/26<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nBiohyalur\u2122 \u0219i Biohyalur\u2122 HV \/ manufacturer Biotech Vision Care PVT. Ltd, India
\nRef. ANMDMR: 646\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nVentilatoare Trilogy Evo, Trilogy Evo O2, Trilogy EV300 \/ manufacturer Philips Respironics, Inc., SUA
\nRef. ANMDMR: 647\/26<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nDat\u0103 de expirare incorect\u0103 pe eticheta kitului DALI 750 \/ manufacturer Fresenius Medical Care AG, Germania
\nRef. ANMDMR: 657\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nOrbis Medication \/ manufacturer DH Healthcare GmbH, Germania
\nRef. ANMDMR: 666\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nNon-Tamperproof Battery Door \/ manufacturer Advanced Bionics LLC, SUA
\nRef. ANMDMR: 673\/26<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nEyevisc\u2122 \/ manufacturer Biotech Visioncare Pvt. Ltd., India
\nRef. ANMDMR: 677\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nAneurysmFlow \/ manufacturer Philips Medical Systems Nederland BV, Tarile de Jos
\nRef. ANMDMR: 678\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nCatetere Swan Ganz \/ manufacturer Edwards Lifesciences LLC, SUA
\nRef. ANMDMR: 679\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\n Aplicatie Dexcom G7 iOS \/ G7 Watch iOS \/ manufacturer Dexcom, Inc., SUA
\nRef. ANMDMR: 681\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nActivit\u0103\u021bi de service pentru sistemele laser CO2 \u0219i sistemele VersaPulse PowerSuite (VPPS) cu lungime de und\u0103 dubl\u0103 (DW) \/ manufacturer Lumenis Ltd., Israel
\nRef. ANMDMR: 683\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\n3 Dimensions\u2122 Mammography System and Selenia\u00ae Dimensions\u00ae Mammography System \/ manufacturer Hologic, Inc., SUA
\nRef. ANMDMR: 685\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nGetinge Steam Sterilizers \/ manufacturer Getinge
\nRef. ANMDMR: 686\/26<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nLINK Prosthesis Head B \/ manufacturer Waldemar Link GmbH & Co.KG, Germania
\nRef. ANMDMR: 692\/26<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nAdhese 2 DC VivaPen Kits and DC Cannulas for VivaPen \/ manufacturer Ivoclar Vivadent AG, Liechtenstein
\nRef. ANMDMR: 693\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nAutomated Impella Controller (AIC) \/ manufacturer Abiomed Inc., SUA
\nRef. ANMDMR: 695\/26<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nForceps t\u0103iere Olympus PK\/PKS\/Everest \/ manufacturer Gyrus ACMI, Inc. (Olympus Surgical Technologies America), SUA
\nRef. ANMDMR: 696\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nOrbis Medication \/ manufacturer DH Healthcare GmbH, Germania
\nRef. ANMDMR: 697\/26<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nImplant SPII Model Lubinus Hip Stems \/ manufacturer Waldemar Link GmbH & Co.KG, Germania
\nRef. ANMDMR: 698\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nPanel QIAstat-Dx Gastrointestinal \/ manufacturer QIAGEN GmbH, Germania
\nRef. ANMDMR: 705\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nHalat chirurgical Secu-Drape\u00ae \/ manufacturer Sengewald Klinikprodukte GmbH, Germania
\nRef. ANMDMR: 706\/26<\/p>\n

USER INFORMATION<\/strong>
\nDispozitiv marClamp Cut IQ \/ manufacturer KLS Martin SE & Co. KG, Germania
\nRef. ANMDMR: 709\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nAptiva CTD Essential Controls \/ manufacturer Inova Diagnostics, Inc., SUA
\nRef. ANMDMR: 710\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nYeastone Broth \/ manufacturer Remel Inc, SUA
\nRef. ANMDMR: 711\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSistem Olympus Soltive\u2122 SuperPulsed Laser \/ manufacturer Gyrus ACMI, Inc. (Olympus Surgical Technologies America), SUA
\nRef. ANMDMR: 713\/26<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nCampylobacter jejuni subsp. jejuni derived from ATCC\u00ae 29428\u2122 \/ manufacturer Microbiologics, Inc., SUA
\nRef. ANMDMR: 2090\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nVue Motion V12 \/ manufacturer Philips Medical Systems Nederland B.V., Tarile de Jos
\nRef. ANMDMR: 18920\/26<\/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 2026 USER INFORMATION Monitoare pacient Philips IntelliVue\/ manufacturer Philips Medizin Systeme B\u00f6blingen GmbH, […]<\/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-12105","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\/12105","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=12105"}],"version-history":[{"count":1,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/posts\/12105\/revisions"}],"predecessor-version":[{"id":12108,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/posts\/12105\/revisions\/12108"}],"wp:attachment":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/media?parent=12105"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/categories?post=12105"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/tags?post=12105"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}