SUMMARY OF FIELD SAFETY NOTIFICATIONS / DECEMBER 2024
PRODUCT RECALL
Anesthesia system: Flow-i C20, Flow-i C30, Flow-i C40, Flow-c, Flow-e / manufacturer Maquet Critical Care AB, Suedia
Ref. ANMDMR: 302.603/24
USER INFORMATION
Bobine SENSE XL Torso (1.5T şi 3.0T) / manufacturer Philips Healthcare, Olanda
Ref. ANMDMR: 304.125/24
USER INFORMATION
Trilogy Evo, Trilogy Evo O2, Trilogy EV300 / manufacturer Philips Respironics, Inc., SUA
Ref. ANMDMR: 306.433/24
PRODUCT RECALL
Device intended for preparation of cements: Synimix VTP Mixer System / manufacturer Synergie Ingénierie Medicale, Franța
Ref. ANMDMR: 307.277c/24
USER INFORMATION
Single-Use Osteochondral Autograft Transfer System / manufacturer Arthrex INC, SUA
Ref. ANMDMR: 307.364/24
USER INFORMATION
Tubing set / manufacturer Baxter Healthcare SA, Elveția
Ref. ANMDMR: 307.365/24
USER INFORMATION
ANIOSPRAY QUICK, ANIOS QUICK WIPES / manufacturer Laboratoires Anios, Franta
Ref. ANMDMR: 307.369/24
USER INFORMATION
DENTASEPT SPRAY 60 PRO / manufacturer D.M.D, Franta
Ref. ANMDMR: 307.370/24
PRODUCT RECALL
Disposable Bipolar Pencil 25GA / manufacturer Kirwan Surgical Products LLC, USA
Ref. ANMDMR: 307.372/24
USER INFORMATION
EZ Glide Aortic Cannulae / manufacturer Edwards Lifesciences LLC, USA
Ref. ANMDMR: 307.375/24
USER INFORMATION
Neonatal ventilator family SOPHIE / manufacturer Fritz Stephan GmbH, Germania
Ref. ANMDMR: 307.380/24
USER INFORMATION
Vidas Myoglobine / manufacturer bioMérieux SA, Franta
Ref. ANMDMR: 307.383/24
PRODUCT RECALL
Gubisch Osteotom 20cm / manufacturer Medicon eG, Germania
Ref. ANMDMR: 307.402/24
USER INFORMATION
GLUCOSE liquicolor / manufacturer Human Gesellschaft für Biochemica und Diagnostica mbH, Germania
Ref. ANMDMR: 307.407/24
USER INFORMATION
Incorrect display of medication with CGM CLINICAL Medication / manufacturer CompuGroup Medical Software GmbH, Germania
Ref. ANMDMR: 307.410/24
USER INFORMATION
Piezowave 2 Control UNIT / manufacturer Richard Wolf GmbH, Germania
Ref. ANMDMR: 307.481/24
USER INFORMATION
Foley catheters, Prostatic catheters, Urinary diversion devices, Neoplex® urethral catheters without balloon, Urethral bougies, Urodynamic catheters, Percutaneous nephrostomy catheters, Supra-pubic drainage set, Surgical drainage devices / manufacturer Coloplast A/S, Danemarca
Ref. ANMDMR: 307.484/24
USER INFORMATION
Sistem Philips Allura Xper / manufacturer Philips Medical Systems Nederland BV, Olanda
Ref. ANMDMR: 307.486/24
USER INFORMATION
Idylla™ Instrument / manufacturer Biocartis NV, Belgia
Ref. ANMDMR: 307.487/24
USER INFORMATION
Kombi / manufacturer Physiomed Elektromedizin AG, Germania
Ref. ANMDMR: 307.493/24
USER INFORMATION
3M™ Transbond™ Plus Self-Etching Primer / manufacturer 3M Unitek Corporation, USA
Ref. ANMDMR: 307.518/24
USER INFORMATION
Single use Biofill infiltration cannula / manufacturer Human Med AG, Germania
Ref. ANMDMR: 307.522/24
USER INFORMATION
VITROS® Chemistry Products DGXN / manufacturer QuidelOrtho (Ortho Clinical Diagnostics Inc), SUA
Ref. ANMDMR: 307.567/24
USER INFORMATION
SpeedControl Dial utilized with SmartDrive MX2+ Power Assist Device / manufacturer Max Mobility LLC, SUA
Ref. ANMDMR: 307.568/24
PRODUCT RECALL
Canule arteriale etichetate greșit / manufacturer Medtronic, Inc., SUA
Ref. ANMDMR: 307.570/24
USER INFORMATION
Stimulatoare cardiace bicamerale (DR) cu durată de viață standard (SL) și durată de viață extinsă (EL) ACCOLADE™, PROPONENT™, ESSENTIO™, și ALTRUA™ 2; și stimulatoare cardiace pentru terapie de resincronizare cardiacă (CRT-P) VISIONIST™ și VALITUDE™/ manufacturer Cardiac Pacemaker Inc, SUA
Ref. ANMDMR: 307.571/24
PRODUCT RECALL
Single Use Mechanical Lithotriptor V / manufacturer Olympus Medical Systems Corporation, Japonia
Ref. ANMDMR: 307.680/24
USER INFORMATION
Compatibilitatea seringii de heparină cu aparatele de dializă: 4008H, 4008B, 4008S, Art(Standard/Universal), Prometheus / manufacturer Fresenius Medical Care AG, Germania
Ref. ANMDMR: 307.736/24
USER INFORMATION
Evo IQ Large Volumetric Pumps (LVP) / manufacturer Baxter Healthcare SA, Elveția
Ref. ANMDMR: 307.752/24
USER INFORMATION
Redmount – mounting bracket Space/ manufacturer Hestomed GmbH, Germania
Ref. ANMDMR: 307.753/24
USER INFORMATION
Rezultate Serratia marcescens fals pozitive pe panoul BIOFIRE BCID2 atunci când este utilizat împreună cu anumite loturi de flacoane de cultură BACT/ALERT®/ manufacturer BioFire Diagnostics, LLC, USA
Ref. ANMDMR: 307.754/24
USER INFORMATION
THUNDERBEAT Type S Hand Instruments / manufacturer Olympus Medical Systems Corporation, Japonia
Ref. ANMDMR: 307.755/24
USER INFORMATION
Cartuș BD PCR / manufacturer Becton, Dickinson and Company, USA
Ref. ANMDMR: 307.757/24
USER INFORMATION
MSOT Acuity Echo CE, MSOT Acuity Research Systems, MSOT Acuity Echo Research Systems / manufacturer / iThera Medical GmbH, Germania
Ref. ANMDMR: 307.768/24
USER INFORMATION
Figulla Flex II ASD and its Procedure Pack / manufacturer Occlutech GmbH, Germania
Ref. ANMDMR: 307.769/24
USER INFORMATION
Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems / manufacturer GE Medical Systems Israel, Functional Imaging, Israel
Ref. ANMDMR: 307.770/24
PRODUCT RECALL
Nobel Biocare N1 TiUltra Implants / manufacturer Nobel Biocare AB, Suedia
Ref. ANMDMR: 307.773/24
USER INFORMATION
BeneFusion nSP syringe pumps / manufacturer Shenzhen Mindray Scientific Co., Ltd., China
Ref. ANMDMR: 307.774/24
USER INFORMATION
Single Use Mechanical Lithotriptor V / manufacturer Olympus Medical Systems Corporation, Japonia
Ref. ANMDMR: 307.779/24
PRODUCT RECALL
FABCO Ivalon eye wicks, cellulose surgical spears and anatomical nasal pack with tube / manufacturer Medsorb Dominicana S.A., Republica Dominicană
Ref. ANMDMR: 307.780/24
USER INFORMATION
Sirolimus Eluting Coronary Stent System / manufacturer Translumina GmbH, Germania
Ref. ANMDMR: 307.783/24
USER INFORMATION
BORA UP 2080 OP 230V 50/60 Hz / manufacturer ATMOS MedizinTechnik GmbH & Co. KG, Germania
Ref. ANMDMR: 307.785/24
USER INFORMATION
Vaporizatoare : Tec 6 Plus și Tec 800 / manufacturer Datex-Ohmeda, Inc, USA
Ref. ANMDMR: 307.786/24
PRODUCT RECALL
Sterile Ophthalmic surgical sets: TRUPACK® / manufacturer Trusetal Verbandstoffwerk GmbH, Germania
Ref. ANMDMR: 307.790/24
USER INFORMATION
Forceps/Irrigation Plug (Isolated Type) / manufacturer
Ref. ANMDMR: 72/25
PRODUCT RECALL
DeltaCut Biopsy – extraction of tissue specimen / manufacturer PAJUNK GmbH Medizintechnologie, Germania
Ref. ANMDMR: 80/25
USER INFORMATION
Ultrasound Surgical Unit / manufacturer Olympus Medical Systems Corporation, Japonia
Ref. ANMDMR: 147/25
USER INFORMATION
Stent cu Sistem de introducere cu electrocauter AXIOS™ / manufacturer Boston Scientific Corporation, USA
Ref. ANMDMR: 163/25
USER INFORMATION
Reagent Expired (RE) Result Code Potentially Not Being Produced When Signal Reagent (SR)Pack Is Expired on VITROS® 3600, 5600 and XT 7600 Systems / manufacturer QuidelOrtho (Ortho Clinical Diagnostics Inc), USA
Ref. ANMDMR: 382/25
USER INFORMATION
VIDAS® CK-MB / manufacturer bioMérieux SA, Franța
Ref. ANMDMR: 384/25
USER INFORMATION
Difuzoare Edifier / manufacturer Draeger Medical System, Inc., SUA
Ref. ANMDMR: 386/25
Please note: If you have questions regarding any of the aforementioned information, please contact the issuer of the field safety notification directly.