{"id":11170,"date":"2025-08-25T08:00:35","date_gmt":"2025-08-25T05:00:35","guid":{"rendered":"https:\/\/www.anm.ro\/en\/?p=11170"},"modified":"2025-08-25T10:26:42","modified_gmt":"2025-08-25T07:26:42","slug":"sumarul-notificarilor-in-materie-de-siguranta-in-teren-iulie-2025","status":"publish","type":"post","link":"https:\/\/www.anm.ro\/en\/sumarul-notificarilor-in-materie-de-siguranta-in-teren-iulie-2025\/","title":{"rendered":"Summary of field safety notifications \/ JULY 2025"},"content":{"rendered":"

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

USER INFORMATION<\/strong>
\nBIOFIRE\u00ae Blood Culture Identification 2 (BCID2) Panel \/ manufacturer BioFire Diagnostics, LLC, SUA
\nRef. ANMDMR: 516\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nVIDAS\u00ae HIV DUO AG\/AB (HIV) \/ manufacturer bioM\u00e9rieux SA, Fran\u021ba
\nRef. ANMDMR: 545\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nProtezele vasculare: Gelsoft Plus \u0219i Gelweave \/ manufacturer Vascutek Ltd, Marea Britanie
\nRef. ANMDMR: 563\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nFootswitch 2 pedals \/ manufacturer Richard Wolf GmbH, Germania
\nRef. ANMDMR: 578\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nVentilator Hamilton Medical – Hamilton-C6 \/ manufacturer Hamilton Medical AG, Elve\u021bia
\nRef. ANMDMR: 579\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nAnti-TPO \/ manufacturer ORGENTEC Diagnostika GmbH, Germania
\nRef. ANMDMR: 587\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSTA\u00ae-LIQUID ANTI-Xa \/ manufacturer Diagnostica Stago, Fran\u021ba
\nRef. ANMDMR: 589\/25<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nEndoprotez\u0103 Carotid Wallstent\u2122 Monorail \/ manufacturer Boston Scientific Corporation, SUA
\nRef. ANMDMR: 590\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nMicrostream Advance Intubated CO2
\nFilter Line, VitaLine Intubated CO2 Filter Line \u0219i FilterLine Intubated CO2 Filter Line \/ manufacturer Philips Medizin Systeme B\u00f6blingen GmbH, Germania
\nRef. ANMDMR: 591\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\n Sistem Philips Allura \/ manufacturer Philips Medical Systems Nederland BV, Olanda
\nRef. ANMDMR: 592\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\ncorpuls3 \/ manufacturer GS Elektromedizinische Ger\u00e4te G. Stemple GmbH, Germania
\nRef. ANMDMR: 593\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSisteme RMN Philips- Achieva, Evolution upgrade, Ingenia, Intera, MR 5300, MR 7700 \/ manufacturer Philips Medical Systems Nederland B.V., \u021a\u0103rile de Jos
\nRef. ANMDMR: 594\/25<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nlifecath CT PICC easy \/ manufacturer VYGON Germany GmbH, Germania
\nRef. ANMDMR: 595\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nKitul de acoperire pentru g\u0103uri de bavur\u0103 SureTek \u2122, parte a sistemului de stimulare cerebral\u0103 profund\u0103 Vercise\u2122, care men\u021bine dificult\u0103\u021bile de blocare a clemei \/ manufacturer Boston Scientific Neuromodulation Corporation, SUA
\nRef. ANMDMR: 596\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nFlow meter SWISS optio regflow\/ manufacturer GLOOR AG, Elve\u0163ia
\nRef. ANMDMR: 597\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSuspensie electric\u0103 pentru lift pacien\u021bi POWEO\/ manufacturer SCALEO Medical, Franta
\nRef. ANMDMR: 599\/25<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nVentilator Leoni plus Transport \/ manufacturer L\u00f6wenstein Medical SE & Co. KG, Germania
\nRef. ANMDMR: 658\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nAnalizor de imunologie \/ manufacturer Beckman Coulter, SUA
\nRef. ANMDMR: 660\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nDexcom G7 CGM App and Dexcom ONE+ CGM App \/ manufacturer Dexcom, Inc., SUA
\nRef. ANMDMR: 661\/25<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nAXS_TOME Papillotom \/ manufacturer Fujifilm medwork GmbH, Germania
\nRef. ANMDMR: 662\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nMasa opera\u021bie Corin \/ manufacturer MAQUET GmbH, Germania
\nRef. ANMDMR: 663\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nVITROS Chemistry Products Ca Slides \/ manufacturer QuidelOrtho (Ortho Clinical Diagnostics Inc), SUA
\nRef. ANMDMR: 664\/25<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nAce \/ manufacturer Spiggle & Theis Medizintechnik GmbH, Germania
\nRef. ANMDMR: 665\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSisteme RMN \/ manufacturer GE Medical Systems LLC, SUA
\nRef. ANMDMR: 666\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\ncroBEE\u2122NA16 Nucleic Acid Extraction System (Plus) \/ manufacturer GeneProof a.s., Republica Ceh\u0103
\nRef. ANMDMR: 667\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nAutomated Impella Controller (AIC)\/ manufacturer Abiomed Inc., SUA
\nRef. ANMDMR: 668\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nMasa chirurgicala TruSystem 7000\/ manufacturer Baxter Medical Systems GmbH +Co. KG; Germania
\nRef. ANMDMR: 669\/25<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nSistem IPC Powerease \/ manufacturer Medtronic Xomed Inc., SUA
\nRef. ANMDMR: 670\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nGenerator electrochirurgical ESG-410\/ manufacturer Olympus Winter & Ibe GmbH, Germania
\nRef. ANMDMR: 671\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nExtension lines for single use \/ manufacturer Zibo Qiaosend Medical Articles Co., Ltd., China
\nRef. ANMDMR: 674\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nReceptor – Dexcom One, Dexcom G7 \u015fi Dexcom One+ \/ manufacturer Dexcom, Inc., SUA
\nRef. ANMDMR: 675\/25<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nCelsite\u00ae Babyport \/ manufacturer B.Braun Medical SAS, Fran\u0163a
\nRef. ANMDMR: 676\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSonde defibrilare ePTFE RELIANCE \/ manufacturer Cardiac Pacemaker Inc, SUA
\nRef. ANMDMR: 677\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nCircuite de respira\u021bie\/ventila\u021bie \u00eenc\u0103lzite VentStar Plus pentru nou-n\u0103scu\u021bi \/ manufacturer Dr\u00e4gerwerk AG & Co. KGaA, Germania
\nRef. ANMDMR: 679\/25<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nStraumann\u00ae Anatomic Healing Abutments \/ manufacturer Institut Straumann AG Elve\u0163ia
\nRef. ANMDMR: 680\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nAVANOS* CORFLO* Nasogastric \/ Nasointestinal Feeding Tubes and AVANOS* CORTRAK* 2 NASOGASTRIC \/ NASOINTESTINAL FEEDING TUBE With Electromagnetic Transmitting Stylet \/ manufacturer Avanos Medical Inc., SUA
\nRef. ANMDMR: 681\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nEchipament de hemodializ\u0103 Surdial X & Surdial 55 Plus \/ manufacturer Nipro Corporation, Japonia
\nRef. ANMDMR: 684\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSharesource Adequest software version 2.10.1\/ manufacturer Baxter Healthcare SA, Elve\u0163ia
\nRef. ANMDMR: 685\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nPomp\u0103 volumetric\u0103 Agilia Connect VP \/ manufacturer Fresenius Kabi AG, Germania
\nRef. ANMDMR: 686\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nBIOFIRE\u00ae FILMARRAY\u00ae TORCH System \/ manufacturer BioFire Diagnosticss, LLC, SUA
\nRef. ANMDMR: 689\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSistem robotic chirurgical da Vinci Xi \u0219i da Vinci X \/ manufacturer Intuitive Surgical, Inc., SUA
\nRef. ANMDMR: 691\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nAce Huber POLYPERF \/ manufacturer Perouse Medical, Fran\u021ba
\nRef. ANMDMR: 692\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nGeneratoare de impulsuri implantabile (IPG) pentru stimulare cerebral\u0103 profund\u0103 (DBS) Vercise Genus \u2122 cu \u00eentrerupere\/\u00eentreruperi a\/ale firului de trecere (FT) \/ manufacturer Boston Scientific Neuromodulation Corporation, SUA
\nRef. ANMDMR: 693\/25<\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nColor Cuff\u00ae Sterile Disposable Tourniquet Cuffs \/ manufacturer Stryker Instruments a division of Stryker Corporation, SUA
\nRef. ANMDMR: 724\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSistem CT – XtremeCT \/ manufacturer SCANCO Medical AG, Elve\u021bia
\nRef. ANMDMR: 735\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSistem de acces WATCHMAN TruSeal\u2122 \u0219i WATCHMAN FXD Curve\u2122 \/ manufacturer Boston Scientific Corporation, SUA
\nRef. ANMDMR: 752\/25<\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\ncorpuls3, corpuls3 Touch \/ manufacturer GS Elektromedizinische Ger\u00e4te G. Stemple GmbH, Germania
\nRef. ANMDMR: 753\/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 \/ JULY 2025 USER INFORMATION BIOFIRE\u00ae Blood Culture Identification 2 (BCID2) Panel \/ manufacturer BioFire […]<\/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-11170","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\/11170","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=11170"}],"version-history":[{"count":1,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/posts\/11170\/revisions"}],"predecessor-version":[{"id":11173,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/posts\/11170\/revisions\/11173"}],"wp:attachment":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/media?parent=11170"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/categories?post=11170"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/tags?post=11170"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}