SUMMARY OF FIELD SAFETY NOTIFICATIONS / SEPTEMBER 2026
USER INFORMATION
Ventilator de terapie intensivă elisa / manufacturer Löwenstein Medical Innovation GmbH & Co. KG, Germania
Ref. ANMDMR: 1141/26
USER INFORMATION
Ventilator neonatal LEONI plus HFO /LEONI plus transport / manufacturer Löwenstein Medical SE & Co. KG, Germania
Ref. ANMDMR: 1351/26
PRODUCT RECALL
Defecțiuni ale cablului de prehensor la instrumentele reutilizabile
cu fălci Vinci X, da Vinci Xi și dV5/ manufacturer Intuitive Surgical, Inc., SUA
Ref. ANMDMR: 1484/26
PRODUCT RECALL
Adaptor urologic Ialuadapter® / UroDapter ®/ manufacturer Pharmico Medical Kft, Ungaria
Ref. ANMDMR: 1688/26
PRODUCT RECALL
Gynecare TVT Exact® / manufacturer Ethicon SARL, Elveția
Ref. ANMDMR: 1703/26
USER INFORMATION
Sistem Centricity High Acuity Anesthesia / Critical Care / manufacturer GE Healthcare Finland Oy, Finlanda
Ref. ANMDMR: 1933/26
USER INFORMATION
Masa electrică HE Spectralis / manufacturer CX Engineering sp. z o.o., Polonia
Ref. ANMDMR: 1944/26
USER INFORMATION
Sisteme RM / manufacturer Philips Medical Systems Nederland B.V., Țările de Jos
Ref. ANMDMR: 1945/26
USER INFORMATION
Kit detectare anticorpi Anti-Anexina V IgG / manufacturer ORGENTEC Diagnostika GmbH, Germania
Ref. ANMDMR: 1949/26
PRODUCT RECALL
Olympus Hemostasis Devices / manufacturer Gyrus ACMI, Inc. (Olympus Surgical Technologies America), SUA
Ref. ANMDMR: 1955/26
PRODUCT RECALL
Sfere pasive Northern Digital Inc (NDI) și truse cu ace de biopsie Medtronic / manufacturer Northern Digital Inc., SUA
Ref. ANMDMR: 1960/26
PRODUCT RECALL
Defibrilator extern HeartSine® samaritan® PAD / manufacturer HeartSine Technologies, LTD, Marea Britanie
Ref. ANMDMR:1971/26
PRODUCT RECALL
Defibrilator extern HeartSine® samaritan® PAD / manufacturer HeartSine Technologies, LTD, SUA
Ref. ANMDMR: 1972/26
USER INFORMATION
Electrocardiograf SE-1201 Pro / manufacturer Edan Instruments, Inc., China
Ref. ANMDMR: 1973/26
USER INFORMATION
Monitoare pentru pacienți Philips IntelliVue / manufacturer Philips Medizin Systeme Böblingen GmbH, Germania
Ref. ANMDMR: 1977/26
PRODUCT RECALL
Sfincter urinar artificial Victo / manufacturer Promedon S.A., Argentina
Ref. ANMDMR: 1978/26
PRODUCT RECALL
Set de reactivi HumaMeter A1c Reagent Kit / manufacturer Human Gesellschaft für Biochemica und Diagnostica mbH, Germania
Ref. ANMDMR: 1979/26
USER INFORMATION
Panel diagnostic molecular BIOFIRE Pneumonia Panel plus, BIOFIRE Joint Infection Panel / manufacturer BioFire Diagnostics LLC, SUA
Ref. ANMDMR: 1991/26
USER INFORMATION
Sistem Centricity Enterprise / Centricity PACS/ Workflow Core Services / manufacturer GE Healthcare, SUA
Ref. ANMDMR: 1992/26
PRODUCT RECALL
Canulă BlueLavage® LongBoneTip / manufacturer UTK Solution GmbH, Germania
Ref. ANMDMR: 2016/26
USER INFORMATION
Software imagistică medicală Fluosoft LX / manufacturer Fluoptics SAS, Franța
Ref. ANMDMR: 2017/26
USER INFORMATION
Platformă software Applied Biosystems™ Diomni™ Software / manufacturer Life Technologies Holdings Pte Ltd., Singapore
Ref. ANMDMR: 2020/26
USER INFORMATION
Dispozitiv de ocluzie a apendicelui atrial stâng Amplatzer™ Amulet™ / manufacturer Abbott Medical, SUA
Ref. ANMDMR: 2028/26
USER INFORMATION
Sisteme de imagistică prin rezonanță magnetică (RM) cu imagistică prin tensori de difuzie (DTI) / manufacturer Philips Medical Systems Nederland B.V., Țările de Jos
Ref. ANMDMR: 2037/26
USER INFORMATION
Analizor de chimie clinică DxC 500 AU / manufacturer Beckman Coulter, Inc., SUA
Ref. ANMDMR: 2041/26
PRODUCT RECALL
Produse cu fibră laser SOLTIVE™ / manufacturer Olympus Gyrus ACMI, Inc., SUA
Ref. ANMDMR: 2042/26
USER INFORMATION
Catetere neurochirurgicale Neurovent și Neurodur / manufacturer Raumedic AG, Germania
Ref. ANMDMR: 2050/26
PRODUCT RECALL
Microcatetere Direxion™ și Direxion HI-FLO™ / manufacturer Boston Scientific Corporation, SUA
Ref. ANMDMR: 2052/26
USER INFORMATION
Sistem IntelliSpace Critical Care and Anesthesia (ICCA) / manufacturer Philips Medizin Systeme Böblingen GmbH, Germania
Ref. ANMDMR: 2059/26
USER INFORMATION
Spectral CT / manufacturer Philips Medical Systems Nederland B.V., Țările de Jos
Ref. ANMDMR: 2063/26
USER INFORMATION
Catetere VACS II/III / manufacturer Osypka GmbH, Germania
Ref. ANMDMR: 2066/26
PRODUCT RECALL
Sistem Oculus Biom® 6 / manufacturer Oculus Optikgeräte GmbH, Germania
Ref. ANMDMR: 2067/26
PRODUCT RECALL
Dräger VentStar Resus Neo și VentStar Resuscitaire / manufacturer Drägerwerk AG & Co. KGaA, Germania
Ref. ANMDMR: 2068/26
USER INFORMATION
Nadal® Rota-Adenovirus Test/ manufacturer nal von minden GmbH, Germania
Ref. ANMDMR: 2074/26
USER INFORMATION
Tub de traheostomie Tracoe Vario P și setul Tracoe Experc Vario / manufacturer Tracoe Medical GmbH, Germania
Ref. ANMDMR: 2075/26
USER INFORMATION
Endoscop cu ultrasunete / manufacturer Pentax Medical Corporation, Germania
Ref. ANMDMR: 2089/26
USER INFORMATION
Eroare de cuplu excesiv în sistemul de chirurgie asistată robotic Hugo™ (RAS) / manufacturer Covidien llc, SUA
Ref. ANMDMR: 2095/26
USER INFORMATION
Dexcom G7 iOS App version 2.12 / manufacturer Dexcom, Inc., SUA
Ref. ANMDMR: 2119/26
USER INFORMATION
Cobas c 303 Analytical Unit / manufacturer Roche Diagnostics GmbH, Germania
Ref. ANMDMR: 2122/26
PRODUCT RECALL
Bronwel Night / manufacturer Hälsa Pharma GmbH, Germania
Ref. ANMDMR: 2123/26
USER INFORMATION
Li-Ion Rechargeable Battery / manufacturer GS Elektromedizinische Geräte G. Stemple GmbH, Germania
Ref. ANMDMR: 2129/26
USER INFORMATION
AIC Purge Flag Failures / manufacturer Abiomed Inc., SUA
Ref. ANMDMR: 2130/26
PRODUCT RECALL
CitraLock Syringe 4% / manufacturer Sterisets Manufacturing S.A., Portugalia
Ref. ANMDMR: 2138/26
USER INFORMATION
Dispozitive tip manager de dispozitiv CareLink™ SmartSync™ (SmartSync) / manufacturer Medtronic, Inc., SUA
Ref. ANMDMR: 2151/26
USER INFORMATION
Recomandare privind actualizarea software-ului iPadOS pentru a reduce frecvența deconectărilor Bluetooth de la CareLink™ SmartSync™ / manufacturer Medtronic, Inc., SUA
Ref. ANMDMR: 2152/26
USER INFORMATION
Aplicație Dexcom G7 iOS App / G7 Watch iOS App / G7 Android App / manufacturer Dexcom, Inc., SUA
Ref. ANMDMR: 2161/26
PRODUCT RECALL
Single Use Ligating Device Polyloop / manufacturer Olympus Medical Systems Corporation, Japonia
Ref. ANMDMR: 2163/26
USER INFORMATION
Sistem de diagnosticare cu ultrasunete Philips Lumify / manufacturer Philips Ultrasound LLC., SUA
Ref. ANMDMR: 2190/26
USER INFORMATION
Precision Pointer Electro Magnetic (EM) / manufacturer Stryker Leibinger GmbH & Co. KG, Germania
Ref. ANMDMR: 2207/26
PRODUCT RECALL
Stryker InterPulse System / manufacturer Stryker Instruments USA, SUA
Ref. ANMDMR: 2218/26
USER INFORMATION
Paediatric care bed / manufacturer KayserBetten GmbH & Co. KG, Germania
Ref. ANMDMR: 2221/26
Please note: If you have questions regarding any of the aforementioned information, please contact the issuer of the field safety notification directly.