SUMMARY OF FIELD SAFETY NOTIFICATIONS / JULY 2024
USER INFORMATION
fabian™ HFO / manufacturer Acutronic Medical Systems AG, Elveția
Ref. ANMDMR: 302.584/24
USER INFORMATION
Horizon X-Ray Bone Densitometer (DXA) / manufacturer Hologic, Inc., SUA
Ref. ANMDMR: 303.758/24
USER INFORMATION
LDH-P, opt. DGKC / manufacturer DIALAB – Produktion und Vertrieb von chemisch-technischen Produkten und Laborinstrumenten Gesellschaft m.b.H., Austria
Ref. ANMDMR: 303.866/24
USER INFORMATION
Papaina / manufacturer DIALAB – Produktion und Vertrieb von chemisch-technischen Produkten und Laborinstrumenten Gesellschaft m.b.H., Austria
Ref. ANMDMR: 303.905/24
USER INFORMATION
CPT® Hip System Femoral Stem 12/14 Neck Taper / manufacturer Zimmer Inc., SUA
Ref. ANMDMR: 304.122/24
USER INFORMATION
Sistemul FILMARRAY TORCH / manufacturer BioFire Diagnostics, LLC, SUA
Ref. ANMDMR: 304.124/24
USER INFORMATION
Bobine SENSE XL Torso (1.5T şi 3.0T) / manufacturer Philips Healthcare, Olanda
Ref. ANMDMR: 304.125/24
USER INFORMATION
PST 500 Precision Surgical Table / manufacturer Baxter Medical Systems GmbH +Co. KG, Germania
Ref. ANMDMR: 304.133/24
USER INFORMATION
Ventana anti-CD10 (SP67) Rabbit Monoclonal Primary Antibody / manufacturer Ventana Medical Systems Inc., SUA
Ref. ANMDMR: 304.158/24
PRODUCT RECALL
BioPince™, BioPinceUltra™ and TruCore™ II Automatic Biopsy Instruments / manufacturer Argon Medical Devices, Inc., SUA
Ref. ANMDMR: 304.160/24
USER INFORMATION
Alinity c Proteins Standard / manufacturer Biokit S.A, Spania
Ref. ANMDMR: 304.164/24
USER INFORMATION
DeepUnity Viewer / manufacturer DH Healthcare GmbH, Germania
Ref. ANMDMR: 304.167/24
USER INFORMATION
Oncomine® Dx Express Test Panel / manufacturer Life Technologies Corporation, SUA
Ref. ANMDMR: 304.168/24
PRODUCT RECALL
Wound dressing epicite hydro / manufacturer JeNaCell GmbH, Germania
Ref. ANMDMR: 304.285/24
USER INFORMATION
Provo.X / manufacturer Ganshorn Medizin Electronic GmbH, Germania
Ref. ANMDMR: 304.324/24
USER INFORMATION
Cursor autonom programator Medtronic CareLink™ 2090 / manufacturer Medtronic Inc., SUA
Ref. ANMDMR: 304.325/24
USER INFORMATION
Comutator manual Ziehm #88036 pentru Ziehm 8000, Ziehm Solo, Ziehm Solo FD, Ziehm Vision, Ziehm Vision FD, Ziehm Vision R, Ziehm Vision RFD, Ziehm Vision RFD 3D / manufacturer Ziehm Imaging GmbH, Germania
Ref. ANMDMR: 304.327/24
USER INFORMATION
Handbike Infinity / manufacturer Decon Wheel AB., Suedia
Ref. ANMDMR: 304.330/24
USER INFORMATION
Prucka 3 Amplifiers used with CardioLab and ComboLab systems / manufacturer GE Medical Systems Information Technologies, Inc., SUA
Ref. ANMDMR: 304.332/24
USER INFORMATION
Accu-Chek® Guide system/ manufacturer Roche Diabetes Care GmbH, Germania
Ref. ANMDMR: 304.333/24
USER INFORMATION
BeneHeart C Series / manufacturer Shenzhen Mindray Bio-Medical Electronics Co., Ltd., China
Ref. ANMDMR: 304.334/24
PRODUCT RECALL
MEGADYNE™ MEGA SOFT™ Pediatric Patient Return Electrode / manufacturer Megadyne Medical Products, Inc, SUA
Ref. ANMDMR: 304.357/24
USER INFORMATION
Defective hand switches on mobile X-ray devices/ manufacturer Ziehm Imaging GmbH, Germania
Ref. ANMDMR: 304.358/24
USER INFORMATION
VarioXX² wheelchair / manufacturer novacare® gmbh, Germania
Ref. ANMDMR: 304.359/24
USER INFORMATION
Olympus EndoDis Pro / manufacturer Ecolab Deutschland GmbH, Germania
Ref. ANMDMR: 304.360/24
USER INFORMATION
ORBIS Medication 03.19.x / manufacturer DH Healthcare GmbH, Germania
Ref. ANMDMR: 304.361/24
USER INFORMATION
Wireless Footswitch / manufacturer Gyrus ACMI, Inc. (Olympus Surgical Technologies America), SUA
Ref. ANMDMR: 304.362/24
USER INFORMATION
UMIC Colistin / manufacturer Bruker Daltonics GmbH & Co. KG, Germania
Ref. ANMDMR: 304.412/24
USER INFORMATION
NADAL® Troponin I Test / manufacturer nal von minden GmbH, Germania
Ref. ANMDMR: 304.417/24
USER INFORMATION
Laryngoscope LED handles, green system (reusable) / manufacturer Starkling e.K., Germania
Ref. ANMDMR: 304.430/24
PRODUCT RECALL
VENUS implant systems / manufacturer HumanTech Spine GmbH, Germania
Ref. ANMDMR: 304.445/24
PRODUCT RECALL
Products containing the component vacuum-tight reservoir VHK 71000/ manufacturer Maquet Cardiopulmonary GmbH, Germania
Ref. ANMDMR: 304.448/24
USER INFORMATION
Replacing the power supply unit for care beds in the Ecofit range / manufacturer tecfor care GmbH, Germania
Ref. ANMDMR: 304.454/24
USER INFORMATION
Shimadzu CVS system – Trinias/ manufacturer Shimadzu Corporation, Japonia
Ref. ANMDMR: 304.455/24
PRODUCT RECALL
Peripheral support catheter iVascular sergeant 18 / manufacturer Life Vascular Devices Biotech, S.L., Spania
Ref. ANMDMR: 304.479/24
USER INFORMATION
corPatch easy, corPatch easy pre-connected, corPatch easy pediatric / manufacturer Leonhard Lang GmbH, Austria
Ref. ANMDMR: 304.482/24
PRODUCT RECALL
Ref. ANMDMR: 304.486/24
USER INFORMATION
Tuburi de ventilație auriculară / manufacturer Exmoor Plastics Limited, Marea Britanie
Ref. ANMDMR: 304.487/24
USER INFORMATION
kit BD BACTEC™ MGIT™ 960 PZA / manufacturer Becton Dickinson and Company
Ref. ANMDMR: 304.514/24
USER INFORMATION
Ventilator BiPAP A40 Pro, ventilator BiPAP A40 EFL şi ventilator BiPAP A30 EFL/ manufacturer Philips Respironics, Inc., SUA
Ref. ANMDMR: 304.533/24
USER INFORMATION
Replacing the power supply unit for care beds in the Ecofit Xtra range/ manufacturer tecfor care GmbH, Germania
Ref. ANMDMR: 304.537/24
PRODUCT RECALL
FiberTak™ Suture Anchor with #2 FiberWire® CL, FiberTak™ Suture Anchor, Double Loaded with 1.3 mm SutureTape™, FiberTak™ Suture Anchor, Double Loaded with 1.3 mm SutureTape™, FiberTak™ Suture Anchor #2 FiberWire® CL / manufacturer Arthrex GmbH; Germania
Ref. ANMDMR: 304.539/24
USER INFORMATION
Philips Interventional HemodynaFmic System – IntelliVue X3 / manufacturer Philips Medizin Systeme Böblingen GmbH, Germania
Ref. ANMDMR: 304.540/24
USER INFORMATION
Electrosurgical Generator / manufacturer Olympus Winter & Ibe GmbH, Germania
Ref. ANMDMR: 304.589/24
PRODUCT RECALL
Dräger Alcotest 7000 charging cradle (3700420) / manufacturer Dräger Safety AG & Co. KGaA, Germania
Ref. ANMDMR: 304.590/24
PRODUCT RECALL
EasyConnect™ Adapter for 2 to 4 Lumen Jet Catheter/ manufacturer Carl Reiner GmbH, Germania
Ref. ANMDMR: 304.718/24
USER INFORMATION
Holotype HLA assay kit configurations / manufacturer Omixon Biocomputing Ltd, Ungaria
Ref. ANMDMR: 304.753/24
USER INFORMATION
S-Monovette® Lithium heparin LH, 4,9 ml / manufacturer Sarstedt AG&Co.KG, Germania
Ref. ANMDMR: 304.755/24
USER INFORMATION
ALFA-Flex, BETA-Flex / manufacturer Semeda GmbH, Germania
Ref. ANMDMR: 304.784/24
USER INFORMATION
IRISpec CA/CB/CC / manufacturer Beckman Coulter Ireland, Inc., Irlanda
Ref. ANMDMR: 304.790/24
USER INFORMATION
IRISpec CA/CB/CC / manufacturer Beckman Coulter Ireland, Inc., Irlanda
Ref. ANMDMR: 304.793/24
USER INFORMATION
GPT (ALT), mod. IFCC / manufacturer DIALAB – Produktion und Vertrieb von chemisch-technischen Produkten und Laborinstrumenten Gesellschaft m.b.H., Austria
Ref. ANMDMR: 304.795/24
USER INFORMATION
MEGADYNE™ MEGA SOFT™ and MEGA 2000™ Reusable Patient Return Electrodes / manufacturer Megadyne Medical Products, Inc., SUA
Ref. ANMDMR: 304.798/24
USER INFORMATION
Piccolo® General Chemistry 13 / manufacturer Abaxis Inc., SUA
Ref. ANMDMR: 304.799/24
USER INFORMATION
Ventilatoare LUISA, TIVAN LS, Life One / manufacturer Löwenstein Medical Technology GmbH + Co. KG, Germania
Ref. ANMDMR: 304.801/24
USER INFORMATION
Operator’s Guide & Quick Reference Guide for ZOLL MRI Compatible Ventilator / manufacturer ZOll Medical Corporation, SUA
Ref. ANMDMR: 304.804/24
USER INFORMATION
Instrumente BD Phoenix™ M50 și BD Phoenix™ 100 / manufacturer Becton Dickinson and Company, SUA
Ref. ANMDMR: 304.812/24
USER INFORMATION
Sursa de alimentare a display-ului tactil pentru sistemele AXIOM MULTIX MT, AXIOM MULTIX MP, AXIOM Vertix MD, AXIOM Vertix Solitaire, MULTIX Swing, MULTIX TOP / manufacturer Siemens Healthcare GmbH, Germania
Ref. ANMDMR: 304.813/24
USER INFORMATION
Exoplan – Matera, Galway, Rijeka / manufacturer exocad GmbH, Germania
Ref. ANMDMR: 304.814/24
PRODUCT RECALL
Asqelio™ Preloaded IOL Delivery System / manufacturer AST Products, Inc., SUA
Ref. ANMDMR: 304.815/24
PRODUCT RECALL
Lentile intraoculare CT LUCIA 221P 23.0D & 28.5D / manufacturer Carl Zeiss Meditec AG (CZM AG), Germania
Ref. ANMDMR: 304.816/24
PRODUCT RECALL
RCM6® Resorbable Collagen Membrane 30MM x 40MM / manufacturer Collagen Matrix, Inc, SUA
Ref. ANMDMR: 304.818/24
USER INFORMATION
Tempus LS / manufacturer SCHILLER AG, Elevetia
Ref. ANMDMR: 304.823/24
USER INFORMATION
Trephine Blades / manufacturer MicroSurgical Technology Inc., SUA
Ref. ANMDMR: 304.826/24
USER INFORMATION
Juvelook / manufacturer VAIM Co., Ltd., Coreea
Ref. ANMDMR: 304.831/24
USER INFORMATION
EndoPredict QS Kit UNO & EndoPredict QS Kit DUO/ manufacturer Myriad International GmbH, Germania
Ref. ANMDMR: 304.835/24
USER INFORMATION
ORBIS Medication 03.X/ manufacturer DH Healthcare GmbH, Germania
Ref. ANMDMR: 304.836/24
PRODUCT RECALL
Zementieradapter mit Stößel XL / manufacturer Peter Brehm GmbH, Germania
Ref. ANMDMR: 304.838/24
USER INFORMATION
CARDIOVIT AT-180 / manufacturer SCHILLER AG, Elvetia
Ref. ANMDMR: 304.839/24
USER INFORMATION
mySugr Bolus Calculator / manufacturer mySugr GmbH, Austria
Ref. ANMDMR: 304.840/24
USER INFORMATION
Shimadzu Digital Angiography System:Trinias / manufacturer SHIMADZU Corporation, Japonia
Ref. ANMDMR: 304.841/24
PRODUCT RECALL
Olympus Everest Bipolar Cutting Forceps / manufacturer Olympus Surgical Technologies, SUA
Ref. ANMDMR: 304.842/24
USER INFORMATION
Corneal Irrigator / manufacturer Bausch & Lomb GmbH, Germania
Ref. ANMDMR: 304.843/24
USER INFORMATION
Spiegelberg Silverline® ventricular catheter 8F / manufacturer Spiegelberg GmbH & Co.KG, Germania
Ref. ANMDMR: 304.845/24
USER INFORMATION
Olympus EndoDis Pro / manufacturer Ecolab Deutschland GmbH, Germania
Ref. ANMDMR: 304.849/24
USER INFORMATION
Hyalobarrier® Gel Endo 3 Pack, Hyalobarrier Gel / manufacturer Anika Therapeutics S.r.l., Italia
Ref. ANMDMR: 304.860/24
USER INFORMATION
Sistem de gestionare a temperaturii Arctic Sun™ 5000 / manufacturer Medivance, Inc., SUA
Ref. ANMDMR: 305.059/24
USER INFORMATION
Kit implant HeartMate 3™ LVAS, Controller sistem HeartMate 3™ LVAS, Controller sistem HeartMate 3TM Low Flow / manufacturer Abbott Medical, SUA
Ref. ANMDMR: 305.083/24
PRODUCT RECALL
HPS 2.0 Rod coupler, S=25N/mm, 27mm / manufacturer Paradigm Spine GmbH, Germania
Ref. ANMDMR: 305.123/24
USER INFORMATION
lentilele intraoculare :Aspira-Aa(Safeloader), Aspira-aAY (Safeloader), Diff-aA (Safeloader), Diff-aAY (Safeloader), ToricaDiff-aA (Safeloader), ToricaDiff-aAY (Safeloader), Aspira-aXAY (Safeloader), Aspira-aXA (Safeloader), Triva-aA (Safeloader), Triva-aAY (Safeloader), Triva-aXAY (Safeloader),
TrivaT-aAY (Safeloader) / manufacturer HumanOptics Holding AG, Germania
Ref. ANMDMR: 305.132/24
USER INFORMATION
Reactiv Access HBc Ab / manufacturer Beckman Coulter, SUA
Ref. ANMDMR: 305.149/24
Please note: If you have questions regarding any of the aforementioned information, please contact the issuer of the field safety notification directly.