SUMMARY OF FIELD SAFETY NOTIFICATIONS / AUGUST 2026
PRODUCT RECALL
Ventilatoare Newport™ HT70 și Newport™ HT70 Plus/ manufacturer Covidien llc, SUA
Ref. ANMDMR: 450/25
USER INFORMATION
Stație de anestezie Atlan / manufacturer Drägerwerk AG & Co. KGaA, Germania
Ref. ANMDMR: 970/26
USER INFORMATION
Philips Azurion Systems / manufacturer Philips Medical Systems Nederland BV, Țările de Jos
Ref. ANMDMR: 983/26
PRODUCT RECALL
Set de circuit respirator coaxial / manufacturer Hamilton Medical AG, Elveția
Ref. ANMDMR: 1206/26
USER INFORMATION
Genefill DX / manufacturer BioScience GmbH, Germania
Ref. ANMDMR: 1637/26
USER INFORMATION
Dispozitiv Hemospray Endoscopic Hemostat / manufacturer Cook Endoscopy/Wilson Cook Medical, Inc., SUA
Ref. ANMDMR: 1667/26
PRODUCT RECALL
Adaptor urologic steril Ialudapter / Urodapter / manufacturer Pharmico Medical Kft, Ungaria
Ref. ANMDMR: 1688/26
USER INFORMATION
Ventilatoare meonatale / manufacturer medin Medical Innovation GmbH, Germania
Ref. ANMDMR: 1691/26
PRODUCT RECALL
Implant dentar Roxolid® / manufacturer Institut Straumann AG, Elveția
Ref. ANMDMR: 1695/26
USER INFORMATION
Anti-Spermatozoa Antibody (ASA) serum ELISA / manufacturer Demeditec Diagnostics GmbH, Germania
Ref. ANMDMR: 1697/26
USER INFORMATION
Centrifugă Rotofix 32A / manufacturer Andreas Hettich GmbH, Germania
Ref. ANMDMR: 1700/26
PRODUCT RECALL
Sistem Gynecare TVT Exact® / manufacturer Ethicon SARL, Elveția
Ref. ANMDMR: 1703/26
PRODUCT RECALL
Grefă vasculară Cardioroot Woven grafts / manufacturer Intervascular SAS, Franta
Ref. ANMDMR: 1721/26
USER INFORMATION
Analizor de biochimie Beckman Coulter AU480 / manufacturer Beckman Coulter, Inc., SUA
Ref. ANMDMR: 1724/26
PRODUCT RECALL
Tijă femurală EcoFit® / manufacturer implantcast GmbH, Germania
Ref. ANMDMR: 1730/26
USER INFORMATION
Citometru flux CyFlow™ Counter / manufacturer Sysmex Partec GmbH, Germania
Ref. ANMDMR: 1741/26
USER INFORMATION
Fore Sight Oximeter cable / manufacturer Chirag Shah, SUA
Ref. ANMDMR: 1758/26
PRODUCT RECALL
Sistem Stryke Flow PS and AHTO Tube Set Leaking / manufacturer Stryker Endoscopy, SUA
Ref. ANMDMR: 1769/26
PRODUCT RECALL
Smartbag / manufacturer Fresenius Medical Care AG, Germania
Ref. ANMDMR: 1774/26
USER INFORMATION
Diverse dispositive/manufacturer Shimadzu Corporation, Japonia
Ref. ANMDMR: 1778/26
USER INFORMATION
Cupă acetabulară VarioCup / manufacturer aap Joints GmbH, Germania
Ref. ANMDMR: 1802/26
USER INFORMATION
Sema / manufacturer Schiller AG, Elveția
Ref. ANMDMR: 1803/26
PRODUCT RECALL
Bravo™ CF capsule delivery device / manufacturer Given Imaging, Inc., SUA
Ref. ANMDMR: 1805/26
USER INFORMATION
Sistem Philips Patient Information Center iX / manufacturer Philips Medizin Systeme Böblingen GmbH, Germania
Ref. ANMDMR: 1806/26
PRODUCT RECALL
Olympus Hemostasis Device / manufacturer Gyrus ACMI, Inc. (Olympus Surgical Technologies America), SUA
Ref. ANMDMR: 1810/26
USER INFORMATION
Sistem DermaV / manufacturer Cynosure Lutronic Technology Corporation, Coreea de Sud
Ref. ANMDMR: 1815/26
USER INFORMATION
Problemă software EPIQ Elite v14.0 cu traductorul C5-1 / manufacturer Philips Medical Systems Nederland B.V., Țările de Jos
Ref. ANMDMR: 1826/26
PRODUCT RECALL
Imlant ortopedic / manufacturer Howmedica Osteonics Corp., SUA
Ref. ANMDMR: 1833/26
USER INFORMATION
Thermo Fisher Scientific MAS® Omni•IMMUNE PRO Liquid Assayed Integrated Immunoassay Control / manufacturer Microgenics Corporation, as part of Thermo Fisher Scientific, SUA
Ref. ANMDMR: 1842/26
USER INFORMATION
Software radioterapie VERIQA RT MonteCarlo 3D / manufacturer PTW Freiburg, Germania
Ref. ANMDMR: 1845/26
PRODUCT RECALL
Sistem Impella CP® cu SmartAssist®/ manufacturer Abiomed Inc., SUA
Ref. ANMDMR: 1853/26
USER INFORMATION
Adeziv siliconic Vygon / manufacturer Vygon Germany GmbH, Germania
Ref. ANMDMR: 1854/26
USER INFORMATION
ORBIS Medication / manufacturer DH Healthcare GmbH, SUA
Ref. ANMDMR: 1855/26
USER INFORMATION
Sistem ORBIS Medication / manufacturer DH Healthcare GmbH, SUA
Ref. ANMDMR: 1856/26
USER INFORMATION
Analizoarele din seria iQ200 și analizoarele Iris DxU 840m/850m / manufacturer Beckman Coulter Ireland Inc., Irlanda
Ref. ANMDMR: 1859/26
USER INFORMATION
Nexus / Medikation / manufacturer Nexus / CMC GmbH, Germania
Ref. ANMDMR: 1861/26
PRODUCT RECALL
Catetere angiografice ImagerTM II / manufacturer Boston Scientific Corporation., SUA
Ref. ANMDMR: 1862/26
PRODUCT RECALL
Conectori ANRYV / manufacturer Balt Extrusion SAS, Franta
Ref. ANMDMR: 1867/26
USER INFORMATION
Panou BD Phoenix™ CPO Detect cu 6 godeuri / manufacturer Becton, Dickinson and Company, SUA
Ref. ANMDMR: 1881/26
USER INFORMATION
Palacos® and Copal® pro systems / manufacturer Heraeus Medical GmbH, Germania
Ref. ANMDMR: 1886/26
USER INFORMATION
Trocar cu balon structural Covidien Auto Suture™ și trocar cu vârf bont Covidien Auto Suture™ / manufacturer Covidien IIc, SUA
Ref. ANMDMR: 1907/26
USER INFORMATION
VentStar Resus Neo şi VentStar Resuscitaire / manufacturer Drägerwerk AG & Co. KGaA, Germania
Ref. ANMDMR: 1911/26
PRODUCT RECALL
Tub de traheostomie Shiley™ Hi-Lo Evac cu manșon / manufacturer Covidien llc, SUA
Ref. ANMDMR: 1912/26
USER INFORMATION
Tub de traheostomie Shiley™ Hi-Lo Evac cu manșon/ manufacturer GE Medical Systems Information Technologies, Inc., SUA
Ref. ANMDMR: 1913/26
USER INFORMATION
Li-Ion Rechargeable Battery / manufacturer GS Elektromedizinische Geräte G. Stemple GmbH, Germania
Ref. ANMDMR: 1915/26
USER INFORMATION
Nova StatStrip®(Gen 2) Glucose and Glucose/β-Ketone Hospital Meter Systems / manufacturer Nova Biomedical Cooporation, SUA
Ref. ANMDMR: 1916/26
PRODUCT RECALL
Trilogy Delivery Catheter / manufacturer JenaValve Technology Inc, SUA
Ref. ANMDMR: 1917/26
USER INFORMATION
Dispozitiv Olympus POWERSEAL / manufacturer Gyrus ACMI, Inc. (Olympus Surgical Technologies America), SUA
Ref. ANMDMR: 1925/26
USER INFORMATION
ORBIS Medication / manufacturer DH Healthcare GmbH, Germania
Ref. ANMDMR: 1928/26
USER INFORMATION
Sistem DeepUnity PACSonWEB / manufacturer DH Healthcare GmbH, Germania
Ref. ANMDMR: 1930/26
USER INFORMATION
Sistem Centricity High Acuity Anesthesia / Critical Care / manufacturer GE Healthcare Finland Oy, Finlanda
Ref. ANMDMR: 1933/26
USER INFORMATION
Test QIAstat-Dx® Gastrointestinal Panel 2 / manufacturer QIAGEN GmbH, Germania
Ref. ANMDMR: 1934/26
USER INFORMATION
Disposable Needle Guide /manufacturer Wellgo Medical Products Gmbh, Germania
Ref. ANMDMR: 1939/26
PRODUCT RECALL
EYEFILL™ C Cohesive Ophthalmic Viscoelastic Devices (OVDs)/ manufacturer Bausch & Lomb Incorporated, SUA
Ref. ANMDMR: 1940/26
USER INFORMATION
Sistem FDR Visionary Suite/ manufacturer Shimadzu Corporation, Japonia
Ref. ANMDMR: 1941/26
Please note: If you have questions regarding any of the aforementioned information, please contact the issuer of the field safety notification directly.