SUMMARY OF FIELD SAFETY NOTIFICATIONS / JULY 2025
USER INFORMATION
BIOFIRE® Blood Culture Identification 2 (BCID2) Panel / manufacturer BioFire Diagnostics, LLC, SUA
Ref. ANMDMR: 516/25
USER INFORMATION
VIDAS® HIV DUO AG/AB (HIV) / manufacturer bioMérieux SA, Franța
Ref. ANMDMR: 545/25
USER INFORMATION
Protezele vasculare: Gelsoft Plus și Gelweave / manufacturer Vascutek Ltd, Marea Britanie
Ref. ANMDMR: 563/25
USER INFORMATION
Footswitch 2 pedals / manufacturer Richard Wolf GmbH, Germania
Ref. ANMDMR: 578/25
USER INFORMATION
Ventilator Hamilton Medical – Hamilton-C6 / manufacturer Hamilton Medical AG, Elveția
Ref. ANMDMR: 579/25
USER INFORMATION
Anti-TPO / manufacturer ORGENTEC Diagnostika GmbH, Germania
Ref. ANMDMR: 587/25
USER INFORMATION
STA®-LIQUID ANTI-Xa / manufacturer Diagnostica Stago, Franța
Ref. ANMDMR: 589/25
PRODUCT RECALL
Endoproteză Carotid Wallstent™ Monorail / manufacturer Boston Scientific Corporation, SUA
Ref. ANMDMR: 590/25
USER INFORMATION
Microstream Advance Intubated CO2
Filter Line, VitaLine Intubated CO2 Filter Line și FilterLine Intubated CO2 Filter Line / manufacturer Philips Medizin Systeme Böblingen GmbH, Germania
Ref. ANMDMR: 591/25
USER INFORMATION
Sistem Philips Allura / manufacturer Philips Medical Systems Nederland BV, Olanda
Ref. ANMDMR: 592/25
USER INFORMATION
corpuls3 / manufacturer GS Elektromedizinische Geräte G. Stemple GmbH, Germania
Ref. ANMDMR: 593/25
USER INFORMATION
Sisteme RMN Philips- Achieva, Evolution upgrade, Ingenia, Intera, MR 5300, MR 7700 / manufacturer Philips Medical Systems Nederland B.V., Țările de Jos
Ref. ANMDMR: 594/25
PRODUCT RECALL
lifecath CT PICC easy / manufacturer VYGON Germany GmbH, Germania
Ref. ANMDMR: 595/25
USER INFORMATION
Kitul de acoperire pentru găuri de bavură SureTek ™, parte a sistemului de stimulare cerebrală profundă Vercise™, care menține dificultățile de blocare a clemei / manufacturer Boston Scientific Neuromodulation Corporation, SUA
Ref. ANMDMR: 596/25
USER INFORMATION
Flow meter SWISS optio regflow/ manufacturer GLOOR AG, Elveţia
Ref. ANMDMR: 597/25
USER INFORMATION
Suspensie electrică pentru lift pacienți POWEO/ manufacturer SCALEO Medical, Franta
Ref. ANMDMR: 599/25
PRODUCT RECALL
Ventilator Leoni plus Transport / manufacturer Löwenstein Medical SE & Co. KG, Germania
Ref. ANMDMR: 658/25
USER INFORMATION
Analizor de imunologie / manufacturer Beckman Coulter, SUA
Ref. ANMDMR: 660/25
USER INFORMATION
Dexcom G7 CGM App and Dexcom ONE+ CGM App / manufacturer Dexcom, Inc., SUA
Ref. ANMDMR: 661/25
PRODUCT RECALL
AXS_TOME Papillotom / manufacturer Fujifilm medwork GmbH, Germania
Ref. ANMDMR: 662/25
USER INFORMATION
Masa operație Corin / manufacturer MAQUET GmbH, Germania
Ref. ANMDMR: 663/25
USER INFORMATION
VITROS Chemistry Products Ca Slides / manufacturer QuidelOrtho (Ortho Clinical Diagnostics Inc), SUA
Ref. ANMDMR: 664/25
PRODUCT RECALL
Ace / manufacturer Spiggle & Theis Medizintechnik GmbH, Germania
Ref. ANMDMR: 665/25
USER INFORMATION
Sisteme RMN / manufacturer GE Medical Systems LLC, SUA
Ref. ANMDMR: 666/25
USER INFORMATION
croBEE™NA16 Nucleic Acid Extraction System (Plus) / manufacturer GeneProof a.s., Republica Cehă
Ref. ANMDMR: 667/25
USER INFORMATION
Automated Impella Controller (AIC)/ manufacturer Abiomed Inc., SUA
Ref. ANMDMR: 668/25
USER INFORMATION
Masa chirurgicala TruSystem 7000/ manufacturer Baxter Medical Systems GmbH +Co. KG; Germania
Ref. ANMDMR: 669/25
PRODUCT RECALL
Sistem IPC Powerease / manufacturer Medtronic Xomed Inc., SUA
Ref. ANMDMR: 670/25
USER INFORMATION
Generator electrochirurgical ESG-410/ manufacturer Olympus Winter & Ibe GmbH, Germania
Ref. ANMDMR: 671/25
USER INFORMATION
Extension lines for single use / manufacturer Zibo Qiaosend Medical Articles Co., Ltd., China
Ref. ANMDMR: 674/25
USER INFORMATION
Receptor – Dexcom One, Dexcom G7 şi Dexcom One+ / manufacturer Dexcom, Inc., SUA
Ref. ANMDMR: 675/25
PRODUCT RECALL
Celsite® Babyport / manufacturer B.Braun Medical SAS, Franţa
Ref. ANMDMR: 676/25
USER INFORMATION
Sonde defibrilare ePTFE RELIANCE / manufacturer Cardiac Pacemaker Inc, SUA
Ref. ANMDMR: 677/25
USER INFORMATION
Circuite de respirație/ventilație încălzite VentStar Plus pentru nou-născuți / manufacturer Drägerwerk AG & Co. KGaA, Germania
Ref. ANMDMR: 679/25
PRODUCT RECALL
Straumann® Anatomic Healing Abutments / manufacturer Institut Straumann AG Elveţia
Ref. ANMDMR: 680/25
USER INFORMATION
AVANOS* CORFLO* Nasogastric / Nasointestinal Feeding Tubes and AVANOS* CORTRAK* 2 NASOGASTRIC / NASOINTESTINAL FEEDING TUBE With Electromagnetic Transmitting Stylet / manufacturer Avanos Medical Inc., SUA
Ref. ANMDMR: 681/25
USER INFORMATION
Echipament de hemodializă Surdial X & Surdial 55 Plus / manufacturer Nipro Corporation, Japonia
Ref. ANMDMR: 684/25
USER INFORMATION
Sharesource Adequest software version 2.10.1/ manufacturer Baxter Healthcare SA, Elveţia
Ref. ANMDMR: 685/25
USER INFORMATION
Pompă volumetrică Agilia Connect VP / manufacturer Fresenius Kabi AG, Germania
Ref. ANMDMR: 686/25
USER INFORMATION
BIOFIRE® FILMARRAY® TORCH System / manufacturer BioFire Diagnosticss, LLC, SUA
Ref. ANMDMR: 689/25
USER INFORMATION
Sistem robotic chirurgical da Vinci Xi și da Vinci X / manufacturer Intuitive Surgical, Inc., SUA
Ref. ANMDMR: 691/25
USER INFORMATION
Ace Huber POLYPERF / manufacturer Perouse Medical, Franța
Ref. ANMDMR: 692/25
USER INFORMATION
Generatoare de impulsuri implantabile (IPG) pentru stimulare cerebrală profundă (DBS) Vercise Genus ™ cu întrerupere/întreruperi a/ale firului de trecere (FT) / manufacturer Boston Scientific Neuromodulation Corporation, SUA
Ref. ANMDMR: 693/25
PRODUCT RECALL
Color Cuff® Sterile Disposable Tourniquet Cuffs / manufacturer Stryker Instruments a division of Stryker Corporation, SUA
Ref. ANMDMR: 724/25
USER INFORMATION
Sistem CT – XtremeCT / manufacturer SCANCO Medical AG, Elveția
Ref. ANMDMR: 735/25
USER INFORMATION
Sistem de acces WATCHMAN TruSeal™ și WATCHMAN FXD Curve™ / manufacturer Boston Scientific Corporation, SUA
Ref. ANMDMR: 752/25
USER INFORMATION
corpuls3, corpuls3 Touch / manufacturer GS Elektromedizinische Geräte G. Stemple GmbH, Germania
Ref. ANMDMR: 753/25
Please note: If you have questions regarding any of the aforementioned information, please contact the issuer of the field safety notification directly.