SUMMARY OF FIELD SAFETY NOTIFICATIONS / AUGUST 2025
PRODUCT RECALL
Denti Dental Implant System / manufacturer DenTi System KFT, Ungaria
Ref. ANMDMR: 687/25
PRODUCT RECALL
Magic-Soft / manufacturer REBOTEC Rehabilitationsmittel GmbH, Germania
Ref. ANMDMR: 690/25
USER INFORMATION
PrisMax Systems si TherMax Blood Warmer Units / manufacturer Baxter Healthcare SA, Elveția
Ref. ANMDMR: 716/25
USER INFORMATION
Kit de diagnosticare in vitro (IVDR) ChimerisMonitor IVD / manufacturer BIOTYPE GmbH, Germania
Ref. ANMDMR: 717/25
USER INFORMATION
VITROS Chemistry Products LAC Slides / manufacturer QuidelOrtho (Ortho Clinical Diagnostics Inc), SUA
Ref. ANMDMR: 719/25
PRODUCT RECALL
Dispozitiv de umflare EncoreTM 26, Kit EncoreTM 26 Advantage, Kit NephroMaxTM, Kit UroMaxUltraTM/ manufacturer Boston Scientific Corporation, SUA
Ref. ANMDMR: 720/25
USER INFORMATION
medin-NC3 / manufacturer medin Medical Innovations GmbH, Germania
Ref. ANMDMR: 721/25
USER INFORMATION
Medihoney® Wound and Burn Products / manufacturer Derma Sciences, Inc, Canada
Ref. ANMDMR: 722/25
PRODUCT RECALL
Color Cuff® Sterile Disposable Tourniquet Cuffs / manufacturer Stryker Instruments a division of Stryker Corporation, SUA
Ref. ANMDMR: 724/25
USER INFORMATION
Tracoe Vario Tube/ manufacturer Tracoe Medical GmbH, Germania
Ref. ANMDMR: 725/25
PRODUCT RECALL
ViziShot 2 FLEX (19G) / manufacturer Gyrus ACMI, Inc. (Olympus Surgical Technologies America), SUA
Ref. ANMDMR: 726/25
PRODUCT RECALL
Alcon Standalone Vitrectomy Consumables / manufacturer Alcon Laboratories, Inc., SUA
Ref. ANMDMR: 727/25
USER INFORMATION
Versius Surgeon Console / manufacturer CMR Surgical Ltd, Marea Britanie
Ref. ANMDMR: 728/25
USER INFORMATION
Philips Azurion și Allura cu opțiune UPS monofazată/ manufacturer Philips Medical Systems Nederland BV, Țările de Jos
Ref. ANMDMR: 729/25
USER INFORMATION
Sisteme Allura Xper /manufacturer Philips Medical Systems Nederland BV, Țările de Jos
Ref. ANMDMR: 730/25
PRODUCT RECALL
Reduced irrigation flow in two BSD 515 irrigation handpieces / manufacturer Bürki inno med AG, Elveția
Ref. ANMDMR: 731/25
USER INFORMATION
N-LINEpro / manufacturer MEDlight GmbH, Herford, Germania
Ref. ANMDMR: 733/25
USER INFORMATION
SKULL TRACTION TONG LARGE/ manufacturer Aesculap AG, Germania
Ref. ANMDMR: 736/25
USER INFORMATION
Implant SIGNUS PSL052043 / manufacturer SIGNUS Medizintechnik GmbH, Germania
Ref. ANMDMR: 775/25
PRODUCT RECALL
Electrod de adâncime MICRODEEP® / manufacturer DIXI Medical S.A.S., Franta
Ref. ANMDMR: 776/25
USER INFORMATION
Tentos 4F/ manufacturer optimed Medizinsiche, Germania
Ref. ANMDMR: 832/25
PRODUCT RECALL
Cateterul de evacuare pentru cordul stâng DLP™ nu își păstrează forma / manufacturer Medtronic Inc., SUA
Ref. ANMDMR: 835/25
USER INFORMATION
Analizoare de hematologie UniCel DxH Coulter configurate cu
fotometru LED HGB /manufacturer Beckman Coulter, Inc., SUA
Ref. ANMDMR: 836/25
USER INFORMATION
Ventilatoare din seria SOPHIE 2020 /manufacturer Fritz Stephan GmbH, Germania
Ref. ANMDMR: 837/25
USER INFORMATION
HistoCore PELORIS 3/manufacturer Leica Biosystems Melbourne Pty Ltd, Australia
Ref. ANMDMR: 838/25
USER INFORMATION
SpeedControl Dial component utilized with the SmartDrive MX2+ Power Assist Device / manufacturer Max Mobility LLC, SUA
Ref. ANMDMR: 839/25
USER INFORMATION
BeneVision N1 / manufacturer Shenzhen Mindray Bio-Medical Electronics Co., Ltd., China
Ref. ANMDMR: 858/25
USER INFORMATION
Inspection of Magnet Venting System / manufacturer Siemens Healthcare GmbH, Germania
Ref. ANMDMR: 860/25
PRODUCT RECALL
Endo-Model -M Modular Knee Prosthesis System / manufacturer Waldemar Link GmbH & Co. KG, Germania
Ref. ANMDMR: 861/25
PRODUCT RECALL
Blueflow Venous Stent/ manufacturer Contract Medical International GmbH(dba Heraeus Medevio), Germania
Ref. ANMDMR: 896/25
USER INFORMATION
Evo IQ Large Volumetric Pumps (LVP) / manufacturer Baxter Healthcare SA, Elveția
Ref. ANMDMR: 897/25
USER INFORMATION
Sistem RMN Siemens Magnetom Flow.Neo / manufacturer Siemens Healthcare GmbH, Germania
Ref. ANMDMR: 898/25
USER INFORMATION
Vyntus products with SNIP/RHINO Option / manufacturer Jaeger Medical GmbH, Germania
Ref. ANMDMR: 899/25
PRODUCT RECALL
ELAN 4 Fixed Duraguard/ manufacturer Aesculap AG, Germania
Ref. ANMDMR: 900/25
USER INFORMATION
Sistem RMN / manufacturer Siemens Shenzhen Magnetic Resonance Ltd., China
Ref. ANMDMR: 901/25
USER INFORMATION
ID-Anti-S, Test Serum ID-Anti-M, N, S, s, Fya, Fyb / manufacturer DiaMed GmbH, Elveția
Ref. ANMDMR: 902/25
PRODUCT RECALL
VITUS-Fi Distal Fibula Nail Ø 3.0mm, L 110mm / manufacturer Dieter Marquardt Medizintechnik GmbH, Germania
Ref. ANMDMR: 903/25
PRODUCT RECALL
Instrument implantare proteze Prevision Instruments / manufacturer Aesculap AG, Germania
Ref. ANMDMR: 904/25
PRODUCT RECALL
Padele de defibrilare F7987W / manufacturer FIAB SpA, Italia
Ref. ANMDMR: 935/25
USER INFORMATION
GETINGE 88-5 Washer disinfector / manufacturer Getinge Disinfection AB, Suedia
Ref. ANMDMR: 936/25
USER INFORMATION
Sisteme CT Brilliance, Ingenuity, IQon Spectral CT/ manufacturer Philips Medical Systems Nederland B.V., Țările de Jos
Ref. ANMDMR: 937/25
USER INFORMATION
Fortress Introducer Sheath System / manufacturer Contract Medical International GmbH (dba Heraeus Medevio), Germania
Ref. ANMDMR: 938/25
PRODUCT RECALL
Instrument monitorizare functii vitale: ARGUS PB-3000 / manufacturer Schiller AG, Elveția
Ref. ANMDMR: 939/25
USER INFORMATION
ARTIS pheno/ manufacturer Siemens Healthcare GmbH, Germania
Ref. ANMDMR: 942/25
USER INFORMATION
Stații de anestezie Atlan/ manufacturer Drägerwerk AG & Co. KGaA, Germania
Ref. ANMDMR: 943/25
PRODUCT RECALL
Reusable trocar System / manufacturer Aesculap AG, Germania
Ref. ANMDMR: 944/25
USER INFORMATION
XVIVO Liver Assist Perfusion Set™/ manufacturer XVIVO B.V., Țările de Jos
Ref. ANMDMR: 945/25
USER INFORMATION
Sisteme CT: Brilliance, Ingenuity și IQon Spectral / manufacturer Philips Medical Systems Nederland B.V., Țările de Jos
Ref. ANMDMR: 946/25
Please note: If you have questions regarding any of the aforementioned information, please contact the issuer of the field safety notification directly.