SUMMARY OF FIELD SAFETY NOTIFICATIONS / MAY 2024
USER INFORMATION
Kit de cateter cu balon intra-aortic Arrow® FiberOptix™, Kit de cateter cu balon intra-aortic Arrow® UltraFlex™ / manufacturer Arrow International LLC (Subsidiary of Teleflex Incorporated), SUA
Ref. ANMDMR: 302.648/24
USER INFORMATION
CareEvent & Patient Information Center iX (PlC iX) / manufacturer Philips Medical Systems, SUA
Ref. ANMDMR: 302.676/24
USER INFORMATION
Tempus LS / manufacturer SCHILLER AG, Elveția
Ref. ANMDMR: 302.683/24
PRODUCT RECALL
Syntel® Silicone Thrombectomy Catheter / manufacturer LeMaitre Vascular, Inc, SUA
Ref. ANMDMR: 302.684/24
PRODUCT RECALL
VITELENE INSERT F32MM POST.WALL, VITELENE INSERT I 36MM POST.WALL / manufacturer Aesculap AG, Germania
Ref. ANMDMR: 302.685/24
USER INFORMATION
Patient Information Center(PIC) iX Uninterruptable Power Supply (UPS) Failures / manufacturer Philips Medical Systems, SUA
Ref. ANMDMR: 302.686/24
USER INFORMATION
HistoCore Pegasus, HistoCore Pegasus Plus / manufacturer Leica Biosystems Nussloch GmbH, Germania
Ref. ANMDMR: 302.689/24
USER INFORMATION
Ecofit S, Ecofit S Low, Ecofit S Plus, Ecofit S Low Plus, Ecofit Plus, Ecofit Plus Low, Ecofit S Comfort / manufacturer Tecfor care GmbH, Germania
Ref. ANMDMR: 302.690/24
USER INFORMATION
MiSeq™ Dx Instrument, NextSeq™ 550Dx Instrument, NovaSeq™ 6000Dx Instrument, Illumina DRAGEN™ Server for NextSeq™ 550Dx, Illumina DRAGEN™ Server v4, VeriSeq™ Onsite Server v2 / manufacturer Illumina, Inc., SUA
Ref. ANMDMR: 302.691/24
USER INFORMATION
Phosphorus Inorganic, Molybdate / manufacturer DIALAB – Produktion und Vertrieb von chemisch-technischen Produkten und Laborinstrumenten Gesellschaft m.b.H., Austria
Ref. ANMDMR: 302.692/24
USER INFORMATION
CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE B850 / manufacturer GE Healthcare Finland Oy, Finlanda
Ref. ANMDMR: 302.697/24
USER INFORMATION
Bisturiu calibrul 20 MVR+ cu lamă V-Lance / manufacturer Alcon Laboratories, Inc., SUA
Ref. ANMDMR: 302.738/24
USER INFORMATION
Monitor de sistem / manufacturer Thoratec Corporation, SUA
Ref. ANMDMR: 302.739/24
USER INFORMATION
InstaClear Sheath / manufacturer Gyrus ACMI, Inc. (Olympus Surgical Technologies America), SUA
Ref. ANMDMR: 302.741/24
USER INFORMATION
BD Multitest™ TBNK în 6 culori / manufacturer Becton, Dickinson and Company, SUA
Ref. ANMDMR: 302.795/24
USER INFORMATION
100380A0 leg holder / manufacturer MAQUET GmbH, Germania
Ref. ANMDMR: 302.852/24
PRODUCT RECALL
Arteriofix kit görlitz, Radialis arteriofix kit gener.hosp.hagen, Arteriofix 20g x 80mm / manufacturer B. Braun Melsungen AG, Germania
Ref. ANMDMR: 302.875/24
PRODUCT RECALL
VICRYL™ (polyglactin 910) Suture and VICRYL™ Plus Antibacterial (polyglactin 910) Suture, PDS™ II (polydioxanone) Suture and PDS™ Plus Antibacterial (polydioxanone) Suture, MONOCRYL™ (poliglecaprone 25) Suture and MONOCRYL™ Plus Antibacterial (poliglecaprone 25) Suture / manufactureri Ethicon Inc., SUA si Johnson & Johnson International, Belgia
Ref. ANMDMR: 302.950/24
USER INFORMATION
Cateter intratecal Ascenda™ model 8780, 8781 și 8784 / manufacturer Medtronic Inc., SUA
Ref. ANMDMR: 302.951/24
USER INFORMATION
Flycicle Vision / manufacturer Dosing GmbH, Germania
Ref. ANMDMR: 302.952/24
PRODUCT RECALL
Optima and Prestige Coil Systems / manufacturer Balt USA, SUA
Ref. ANMDMR: 302.953/24
PRODUCT RECALL
Endo-Model Knee System, LINK Endo-Model EVO Knee System / manufacturer Waldemar Link GmbH & Co.KG, Germania
Ref. ANMDMR: 302.960/24
USER INFORMATION
ORBIS Medication 3.x / manufacturer DH Healthcare GmbH, Germania
Ref. ANMDMR: 302.962/24
USER INFORMATION
MultiCut Blade 350, MultiCut Blade 400 / manufacturer Asclepion Laser Technologies GmbH, Germania
Ref. ANMDMR: 302.963/24
USER INFORMATION
Monitoare de pacient BSM-1763, BSM-3562, BSM-3763 și module de intrare AY-661P și AY-663P / manufacturer NIHON KOHDEN Corporation, Japonia
Ref. ANMDMR: 302.975/24
USER INFORMATION
Centricity High Acuity Critical Care (CHA CC) Versiunea 5.0 și cele succesive, cu funcția Order Module (Modul de comenzi) activată; Centricity High Acuity Anesthesia (CHA A) Versiunea 4.2 și cele succesive, cu funcția Order Module (Modul de comenzi) activată / manufacturer GE Healthcare, SUA
Ref. ANMDMR: 302.978/24
USER INFORMATION
Dispozitiv de calibrare HbA1c II / manufacturer Randox Laboratories, Marea Britanie
Ref. ANMDMR: 302.984/24
PRODUCT RECALL
KD-LINE® Extension-Connection Tubing for connection to infusion and transfusion systems / manufacturer KD Medical GmbH Hospital Products, Germania
Ref. ANMDMR: 302.985/24
USER INFORMATION
Achieva 1.5T, Achieva 1.5T Conversion, Achieva 1.5T Initial system, Achieva 3.0T, Achieva 3.0T pentru PET, Achieva 3.0T TX pentru PET, Achieva XR, Evolution upgrade 1.5T, Evolution upgrade 3.0T, Ingenia 1.5T, Ingenia 1.5T CX, Ingenia 1.5T S, Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Ambition S, Ingenia Ambition X, Ingenia Elition X, INGENUITY TF PET MR, Intera 1.5T, Marlin 1.5T, MR 5300, Sistem RM Marlin de 1,5 T, MR-RT, Upgrade-uri MR-RT, Panorama HFO, SmartPath – dStream pentru 1.5T, SmartPath – dStream pentru 3.0T, SmartPath – dStream pentru XR şi 3.0T, SmartPath to Ingenia Elition X, Sonalleve MR-HIFU 3.0T, Upgrade dStream / manufacturer Philips Medical Systems Nederland B.V., Olanda
Ref. ANMDMR: 303.008/24
PRODUCT RECALL
Power supply unit for care beds in the Ecofit Xtra range/ manufacturer tecfor care GmbH, Germania
Ref. ANMDMR: 303.073/24
USER INFORMATION
VITROS® Immunodiagnostic Products Anti-HBs Calibrators / manufacturer QuidelOrtho (Ortho Clinical Diagnostics Inc), Marea Britanie
Ref. ANMDMR: 303.074/24
PRODUCT RECALL
Infusion tube for syringe pumps 150 cm / manufacturer Shandong Lee Med Technology Co., Ltd., China
Ref. ANMDMR: 303.075/24
USER INFORMATION
Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1 on Mako 3.0, 3.1 / manufacturer Stryker Joint Replacement, SUA
Ref. ANMDMR: 303.181/24
USER INFORMATION
Consola principală CentriMag de a 2-a generație / manufacturer Thoratec Switzerland GmbH, Elveția
Ref. ANMDMR: 303.184/24
USER INFORMATION
Endo-Model M Modular Knee Prosthesis System, Endo-Model SL Rotational and Hinge Knee Prosthesis System / manufacturer Waldemar Link GmbH & Co.KG, Germania
Ref. ANMDMR: 303.186/24
USER INFORMATION
AESCULAP AEOS System PV010, AESCULAP AEOS System PV010893 / manufacturer AESCULAP AG, Germania
Ref. ANMDMR: 303.188/24
USER INFORMATION
multiFiltratePRO / manufacturer Fresenius Medical Care AG, Germania
Ref. ANMDMR: 303.189/24
USER INFORMATION
CGM CLINICAL Medication / manufacturer CompuGroup Medical Software GmbH, Germania
Ref. ANMDMR: 303.190/24
USER INFORMATION
ORBIS Medication 03.X / manufacturer DH Healthcare GmbH, Germania
Ref. ANMDMR: 303.193/24
PRODUCT RECALL
E.MOTION PRO / manufacturer AESCULAP AG, Germania
Ref. ANMDMR: 303.194/24
USER INFORMATION
Defibrilator Tempus LS / manufacturer Schiller AG, Elveția
Ref. ANMDMR: 303.195/24
USER INFORMATION
PIC iX Customized Event Catalog Setting Not Copied as Expected From One Unit to
Another/ manufacturer Philips Medical Systems, SUA
Ref. ANMDMR: 303.236/24
USER INFORMATION
Infinity M500 Docking Station / manufacturer Draeger Medical Systems, Inc., SUA
Ref. ANMDMR: 303.278/24
USER INFORMATION
Idylla™ EGFR Mutation Test / manufacturer Biocartis, Belgia
Ref. ANMDMR: 303.285/24
USER INFORMATION
ORBIS Medication 03.X / manufacturer DH Healthcare GmbH, Germania
Ref. ANMDMR: 303.290/24
USER INFORMATION
Medi-Test URYXXON® Stick 10 / manufacturer MACHEREY-NAGEL GmbH & Co.KG, Germania
Ref. ANMDMR: 303.292/24
USER INFORMATION
Medical Ventilator HAMILTON-C6 / manufacturer Hamilton Medical AG, Elvetia
Ref. ANMDMR: 303.296/24
PRODUCT RECALL
Advanta VXT and Flixene Vascular Grafts / manufacturer Atrium Medical Corporation, SUA
Ref. ANMDMR: 303.298/24
PRODUCT RECALL
Biolox® delta Ceramic Femoral Head, M, 36/0 taper 12/14 / manufacturer Zimmer Switzerland Manufacturing GmbH, Elveția
Ref. ANMDMR: 303.342/24
USER INFORMATION
Suprasorb CNP endo Kit Oral / manufacturer Lohmann & Rauscher GmbH & Co.KG, Germania
Ref. ANMDMR: 303.343/24
PRODUCT RECALL
TLIF & PLIF Implants / manufacturer Eit Emerging Implant Technologies GmbH, Germania
Ref. ANMDMR: 303.344/24
USER INFORMATION
ABL800 Basic and ABL8XX FLEX analyzers / manufacturer Radiometer Medical ApS, Danemarca
Ref. ANMDMR: 303.388/24
PRODUCT RECALL
MC3® – Femoral semi-wedges-Batch mixing / manufacturer C2F IMPLANTS, Franta
Ref. ANMDMR: 303.389/24
USER INFORMATION
Defibrilator extern automat BeneHeart D1 / manufacturer Shenzhen Mindray Bio-Medical Electronics Co., Ltd., China
Ref. ANMDMR: 303.394/24
PRODUCT RECALL
Trevo Retrievers/Microcatheters, FlowGate2, Distal Access Catheter (DAC), Synchro / manufacturer Stryker Neurovascular, SUA
Ref. ANMDMR: 303.397/24
Please note: If you have questions regarding any of the aforementioned information, please contact the issuer of the field safety notification directly.