SUMMARY OF FIELD SAFETY NOTIFICATIONS / DECEMBER 2025
USER INFORMATION
Sisteme Philips Allura și Azurion / manufacturer Philips Medical Systems Nederland BV., Țările de Jos
Ref. ANMDMR: 494/25
PRODUCT RECALL
Medihoney® Wound and Burn Products / manufacturer Derma Sciences, inc (in process in transitioning to Acell), Canada
Ref. ANMDMR: 722/25
USER INFORMATION
NIP and Rhinomanometry Components for the Vyntus Devices / manufacturer Jaeger Medical GmbH, Germania
Ref. ANMDMR: 899/25
USER INFORMATION
Analizoare ABL800 Basic și ABL8XX Flex / manufacturer Radiometer Medical ApS, Danemarca
Ref. ANMDMR: 1789/25
PRODUCT RECALL
Seturi HARTMANN care conțin seringi de la manufacturerul MedNet / manufacturer PAUL HARTMANN AG, Germania
Ref. ANMDMR: 1803/25
USER INFORMATION
Mixer gaze SLE1500 & Interflow / manufacturer SLE Limited, Marea Britanie
Ref. ANMDMR: 1805/25
USER INFORMATION
Aplicația dispozitivului de programare pentru clinician Vanta™ – Începere utilizare/ manufacturer Medtronic, Inc., SUA
Ref. ANMDMR: 1815/25
PRODUCT RECALL
Neurostimulator implantabil (INS) Vanta™/ manufacturer Medtronic Inc, SUA
Ref. ANMDMR: 1819/25
USER INFORMATION
Sistemele Philips Incisive CT și CT 5300 / manufacturer Philips Healthcare (Suzhou) Co., Ltd, China
Ref. ANMDMR: 1823/25
USER INFORMATION
Trocar Minop® / manufacturer Aesculap AG, Germania
Ref. ANMDMR: 1832/25
USER INFORMATION
Pompă de perfuzie BD neXus V700 și Pompă de seringă BD neXus S700 / manufacturer Medcaptain Medical Technology Co., Ltd., China
Ref. ANMDMR: 1835/25
USER INFORMATION
basixCOMPAK™ / manufacturer Merit Medical Systems, Inc., SUA
Ref. ANMDMR: 1836/25
USER INFORMATION
Masă operație Otesus / manufacturer MAQUET GmbH, Germania
Ref. ANMDMR: 1858/25
USER INFORMATION
Ambulatory Elastomeric Infusion Pumps / manufacturer Baxter Healthcare SA, Elevetia
Ref. ANMDMR: 1863/25
USER INFORMATION
Tub de transfer LAF1000 / manufacturer Eckert & Ziegler BEBIG GmbH, Germania
Ref. ANMDMR: 1865/25
PRODUCT RECALL
PALAMIX® uno / manufacturer Heraeus Medical GmbH, Germania
Ref. ANMDMR: 1873/25
USER INFORMATION
Analytical Unit Cobas c 703 / manufacturer Roche Diagnostics GmbH, Germania
Ref. ANMDMR: 1889/25
USER INFORMATION
HDL colesterol direct / manufacturer Biosystems S.A., Spania
Ref. ANMDMR: 1892/25
USER INFORMATION
Pachete de proceduri conținând seringi de la manufacturerul MedNet / manufacturer Lohmann & Rauscher International, Germania
Ref. ANMDMR: 1901/25
USER INFORMATION/
Pat Lisa LE / manufacturer FreiStil Tischlerei GmbH & Co. KG, Germania
Ref. ANMDMR: 1902/25
USER INFORMATION
Automated Tube Sorter / manufacturer Sysmex Corporation Japan, Japonia
Ref. ANMDMR: 1910/25
PRODUCT RECALL
Meliseptol foam pure spray cent / manufacturer B.Braun Medical AG, Elveția
Ref. ANMDMR: 1916/25
USER INFORMATION
Sistem de ghidare robotică Mazor X™ / manufacturer Mazor Robotics Ltd., Israel
Ref. ANMDMR: 1919/25
USER INFORMATION
Analizoarele UniCel DxI 600 și 800 / manufacturer Beckman Coulter, Inc., SUA
Ref. ANMDMR: 1923/25
USER INFORMATION
Leksell GammaPlan®/ manufacturer Elekta Solutions AB, Suedia
Ref. ANMDMR: 1933/25
USER INFORMATION
Sistemele Philips Azurion R3.0 / manufacturer Philips Medical Systems Nederland BV, Tarile de Jos
Ref. ANMDMR: 1940/25
USER INFORMATION
Monitor Tempus Pro / manufacturer Remote Diagnostic Technologies Ltd., Marea Britanie
Ref. ANMDMR: 1941/25
USER INFORMATION
Combur10 Test M u 411 Visual 100 Str / manufacturer Roche Diagnostics GmbH, Germania
Ref. ANMDMR: 1946/25
USER INFORMATION
Dexcom One+ iOS CGM App version 1.2.0 / manufacturer Dexcom, Inc., SUA
Ref. ANMDMR: 1952/25
USER INFORMATION
Sisteme de anestezie Carestation seriile 600 și 700/ manufacturer Datex-Ohmeda, Inc, SUA
Ref. ANMDMR: 1953/25
PRODUCT RECALL
Codman Microsensor® Basic kit and Cerelink® ICP sensor Basic kit / manufacturer Integra LifeSciences Production Corporation, SUA
Ref. ANMDMR: 1956/25
USER INFORMATION
IsoSeed® / manufacturer Eckert & Ziegler Bebig GmbH, Germania
Ref. ANMDMR: 1967/25
USER INFORMATION
Alinity ci-series System Control Module (SCM) / manufacturer Abbott Laboratories, SUA
Ref. ANMDMR: 1973/25
USER INFORMATION
Biosynex S.pneumoniae și Biosynex S.pneumoniae BSX / manufacturer Biosynex SA, Franța
Ref. ANMDMR: 1983/25
USER INFORMATION
PALACOS® and COPAL® pro systems / manufacturer Heraeus Medical GmbH, Germania
Ref. ANMDMR: 1991/25
USER INFORMATION
CleanCell M / manufacturer Roche Diagnostics GmbH, Germania
Ref. ANMDMR: 1992/25
USER INFORMATION
Orbis Medication / manufacturer DH Healthcare GmbH, Germania
Ref. ANMDMR: 1998/25
USER INFORMATION
Gelsoft Plus, Gelweave, Thoraflex Hybrid / manufacturer Vascutek Ltd, Marea Britanie
Ref. ANMDMR: 2002/25
USER INFORMATION
Mint Lesion™ / manufacturer Mint Medical GmbH, Germania
Ref. ANMDMR: 2003/25
PRODUCT RECALL
Zimmer® Air Dermatome & Zimmer® Dermatome AN / manufacturer Zimmer Surgical, Inc., SUA
Ref. ANMDMR: 2004/25
PRODUCT RECALL
Stent de apozitie Lumen Axios™ / manufacturer Boston Scientific Corporation, SUA
Ref. ANMDMR: 2006/25
INFORMAȚIE PENT RU UTILIZATORI
Sistem biopsie Brevera®/ manufacturer Hologic, Inc., SUA
Ref. ANMDMR: 2018/25
USER INFORMATION
DxCare / manufacturer DH Healthcare GmbH, Germania
Ref. ANMDMR: 2019/25
USER INFORMATION
Sisteme Philips Azurion R3.1 / manufacturer Philips Medical Systems Nederland BV, Tarile de Jos
Ref. ANMDMR: 2033/25
USER INFORMATION
Sisteme Philips Azurion R2.1.10 și R2.2.10 / manufacturer Philips Medical Systems Nederland BV, Tarile de Jos
Ref. ANMDMR: 2034/25
USER INFORMATION
XN Series BB mode False low Residual WBC count / manufacturer Sysmex Corporation Japan, Japonia
Ref. ANMDMR: 2037/25
USER INFORMATION
Tenos 4F / manufacturer Optimed medizinische Instrumente GmbH, Germania
Ref. ANMDMR: 2049/25
USER INFORMATION
Bubble Sensor / manufacturer Maquet Cardiopulmonary GmbH, Germania
Ref. ANMDMR: 2088/25
USER INFORMATION
Campylobacter jejuni subsp. jejuni derivat din ATCC® 29428™ / manufacturer Microbiologics, Inc., SUA
Ref. ANMDMR: 2090/25
USER INFORMATION
Maxima Diamond Burs / manufacturer Henry Schein Inc., SUA
Ref. ANMDMR: 2099/25
USER INFORMATION
CryoSure-DMSO / manufacturer WAK-Chemie Medical GmbH, Germania
Ref. ANMDMR: 2100/25
Please note: If you have questions regarding any of the aforementioned information, please contact the issuer of the field safety notification directly.