SUMMARY OF FIELD SAFETY NOTIFICATIONS / MARCH 2025
USER INFORMATION
ProPort™ Plastic Implantable Ports / manufacturer ICU Medical Inc, SUA
Ref. ANMDMR: 56/25
USER INFORMATION
DeepUnity PACSonWEB / manufacturer DH Healthcare GmbH, Germania
Ref. ANMDMR: 57/25
USER INFORMATION
Reactiv ELISA Inhibin B Gen II / manufacturer Immunotech s.r.o., Cehia
Ref. ANMDMR: 61/25
USER INFORMATION
Diphoterine Lp / Hexafluorine Lp / manufacturer Prevor, Franța
Ref. ANMDMR: 62/25
USER INFORMATION
HYBRID guidewire / manufacturer BALT EXTRUSION SAS, Franta
Ref. ANMDMR: 63/25
PRODUCT RECALL
Shiley™ Adult Flexible Tracheostomy Tube with TaperGuard™ Cuff Reusable Inner Cannula / manufacturer Medtronic Ireland Limited, Irlanda
Ref. ANMDMR: 64/25
USER INFORMATION
ABL90 FLEX and ABL90 FLEX PLUS Analyzer / manufacturer Radiometer Medical ApS, Danemarca
Ref. ANMDMR: 65/25
USER INFORMATION
Intubation Oral/Nasal Endotracheal Tube / manufacturer Smiths Medical ASD, Inc, SUA
Ref. ANMDMR: 78/25
USER INFORMATION
Kocher forceps, included in the HARTMANN gynaecology and obstetrics sets / manufacturer Paul Hartmann AG, Germania
Ref. ANMDMR: 80/25
USER INFORMATION
Masă chirurgicală TruSystem 7500 / manufacturer Baxter Medical Systems GmbH + Co. KG, Germania
Ref. ANMDMR: 81/25
USER INFORMATION
DeepUnity Diagnost / manufacturer DH Healthcare GmbH, Germania
Ref. ANMDMR: 82/25
PRODUCT RECALL
HeartMate 3 Mobile Power Unit (MPU) / manufacturer Thoratec Corporation, SUA
Ref. ANMDMR: 85/25
USER INFORMATION
FRED easyport / manufacturer SCHILLER AG, Elveția
Ref. ANMDMR: 103/25
USER INFORMATION
Carestation 600 and 750 Series / manufacturer Datex-Ohmeda, Inc, SUA
Ref. ANMDMR: 106/25
PRODUCT RECALL
TLX/TLX Guided Implant Driver / manufacturer Institut Straumann AG, Elveția
Ref. ANMDMR: 108/28
USER INFORMATION
Alinity m System/ manufacturer Abbott Molecular, Inc., SUA
Ref. ANMDMR: 111/25
USER INFORMATION
IntelliVue Philips Patient Monitor 6000 series/ manufacturer Philips Medizin Systeme Böblingen GmbH, Germania
Ref. ANMDMR: 112/25
PRODUCT RECALL
Diamantschleifinstrumente Dental / manufacturer NTI-Kahla GmbH Rotary Dental Instruments, Germania
Ref. ANMDMR: 113/25
USER INFORMATION
CARDIOSAVE Hybrid – Ultrasonic Doppler / manufacturer MAQUET Cardiovascular, LLC, SUA
Ref. ANMDMR: 117/25
USER INFORMATION
3PLUS1®Multilevel Plasma Calibrator Set, MassTox®Antimycotic Drugs, MassCheck®Antimycotic Drugs / manufacturer Chromsystems Instruments & Chemicals GmbH, DE
Ref. ANMDMR: 236/25
USER INFORMATION
Anti-TPO / manufacturer ORGENTEC Diagnostika GmbH, Germania
Ref. ANMDMR: 237/25
USER INFORMATION
Kit reactiv Access Vitamina B12 / manufacturer Beckman Coulter, Inc., SUA
Ref. ANMDMR: 238/25
USER INFORMATION
ORBIS Medication 3.X / manufacturer DH Healthcare GmbH, Germania
Ref. ANMDMR: 239/25
USER INFORMATION
ORBIS Medication 3.x / manufacturer DH Healthcare GmbH, Germania
Ref. ANMDMR: 240/25
PRODUCT RECALL
Custom Tubing Packs – CTP / manufacturer Maquet Cardiopulmonary GmbH, DE
Ref. ANMDMR: 241/25
USER INFORMATION
Anti-TPO / manufacturer ORGENTEC Diagnostika GmbH, Germania
Ref. ANMDMR: 242/25
USER INFORMATION
Hb-sensor type III complete / manufacturer ESCHWEILER GmbH & Co. KG
Ref. ANMDMR: 243/24
PRODUCT RECALL
Cartiva Synthetic Cartilage Implant (SCI) / manufacturer Cartiva Inc., SUA
Ref. ANMDMR: 244/25
USER INFORMATION
Sistem de monitorizare a nervilor NIM Vital™ / manufacturer Medtronic Xomed, Inc., SUA
Ref. ANMDMR: 281/25
USER INFORMATION
MEONA Release V / manufacturer Mesalvo Freiburg GmbH, Germania
Ref. ANMDMR: 282/25
USER INFORMATION
Dispozitivele Giraffe OmniBed și Giraffe OmniBed Carestation / manufacturer GE Healthcare, SUA
Ref. ANMDMR: 283/25
USER INFORMATION
GeneProof Aspergillus PCR Kit / manufacturer GeneProof a.s, Cehia
Ref. ANMDMR: 315/25
PRODUCT RECALL
Gb Onco EGFR / manufacturer Generi Biotech s.r.o, Cehia
Ref. ANMDMR: 316/25
USER INFORMATION
Progressa / manufacturer Hill-Rom, Inc., SUA
Ref. ANMDMR: 317/25
USER INFORMATION
Alinity m System / manufacturer Abbott Molecular, Inc., SUA
Ref. ANMDMR: 318/25
USER INFORMATION
DxC 500 AU Clinical Chemistry Analyzer/ manufacturer Beckman Coulter Inc, SUA
Ref. ANMDMR: 319/25
USER INFORMATION
Anti-TPO IgG / manufacturer DIALAB – Produktion und Vertrieb von chemisch-technischen Produkten und Laborinstrumenten Gesellschaft m.b.H., Austria
Ref. ANMDMR: 320/25
PRODUCT RECALL
4F Amplatzer™ TVLP / manufacturer Abbott Medical, SUA
Ref. ANMDMR: 18676/25
USER INFORMATION
Mobile Phase A MassChrom® Amino Acid Analysis / manufacturer Chromsystems Instruments & Chemicals GmbH, Germania
Ref. ANMDMR: 18720/25
USER INFORMATION
MassChrom® AminoAcids and Acylcarnites from dried blood / manufacturer Chromsystems Instruments & Chemicals GmbH, Germania
Ref. ANMDMR: 19830/25
USER INFORMATION
Cell-Dyn Ruby / manufacturer Abbott Laboratories, SUA
Ref. ANMDMR: 20131/25
PRODUCT RECALL
Hemospray Endoscopic Hemostat / manufacturer Cook Endoscopy / Wilson-Cook Medical, Inc., SUA
Ref. ANMDMR: 20161/25
USER INFORMATION
Endoflow® II / manufacturer Rocamed, Franța
Ref. ANMDMR: 20201/25
PRODUCT RECALL
EVOK Femoral Stem – Standard Offset – Collarless – Cemented – Taper 12/14 – Size 8 / manufacturer Amplitude, Franța
Ref. ANMDMR: 20202/25
USER INFORMATION
DxC 500i Clinical Analyzer / manufacturer Beckman Coulter, Inc., SUA
Ref. ANMDMR: 20203/25
USER INFORMATION
EsophyX® Z+ / manufacturer Merit Medical Systems Inc., SUA
Ref. ANMDMR: 20220/25
USER INFORMATION
PF4 Enhanced®, PF4 IgG / manufacturer Immucor GTI Diagnostics (A Werfen Company), SUA
Ref. ANMDMR: 20231/25
USER INFORMATION
Bioproteza Medtronic Evolut™ PRO+/FX/FX+/ manufacturer Medtronic CoreValve LLC, SUA
Ref. ANMDMR: 20234/25
USER INFORMATION
Anti-TPO IgG / manufacturer DIALAB – Produktion und Vertrieb von chemisch-technischen Produkten und Laborinstrumenten Gesellschaft m.b.H., Germania
Ref. ANMDMR: 20240/25
USER INFORMATION
PlegiStore®, LungProtect®, CelProtect®, StoreProtect Plus®, StoreProtect®, PumpProtect®, Belzer UW® Cold Storage Solution (University of Wisconsin Solution), Belzer MPS® (UW Machine Perfusion Solution) / manufacturer Carnamedica Sp. z o.o., Polonia
Ref. ANMDMR: 20242/25
USER INFORMATION
Centricity Universal Viewer (UV), Centricity PACS-IW (PACS-IW), Centricity Radiology RA600 (RA600) și Centricity Cardiology CA1000 (CA1000) / manufacturer GE Healthcare, SUA
Ref. ANMDMR: 20245/25
USER INFORMATION
Sistem masă chirurgicală TruSystem 7500 / manufacturer Baxter Medical Systems GmbH + Co. KG, Germania
Ref. ANMDMR: 20265/25
USER INFORMATION
RX Cassette Cover / manufacturer Medline International France SAS, Franța
Ref. ANMDMR: 20267/25
USER INFORMATION
4Fr Single Lumen PowerPICC / manufacturer Bard Access Systems Incorporated, SUA
Ref. ANMDMR: 20275/25
PRODUCT RECALL
Strappal® / manufacturer BSN Medical SAS, Franța
Ref. ANMDMR: 20281/25
USER INFORMATION
Kit reactiv Access Vitamina B12 / manufacturer Beckman Coulter, SUA
Ref. ANMDMR: 20289/25
USER INFORMATION
Sistemele de radiologie intervențională – modele: INFX-8000C, INFX-8000F, INFX-8000V, INFX-8000H / manufacturer Canon Medical Systems Corporation, Japonia
Ref. ANMDMR: 20291/25
USER INFORMATION
CGM Clinical Medication / manufacturer CompuGroup Medical Software GmbH, Germania
Ref. ANMDMR: 20300/25
USER INFORMATION
Meona – Release V / manufacturer Mesalvo Freiburg GmbH, Germania
Ref. ANMDMR: 20301/25
USER INFORMATION
Bivona® TTS™ Adjustable Neck Flange Hyperflex™ Tracheostomy Tube / manufacturer Smiths Medical ASD, Inc, SUA
Ref. ANMDMR: 20305/25
USER INFORMATION
Sisteme de tomografie computerizată Revolution CT și Revolution Apex / manufacturer GE Medical Systems LLC, USA
Ref. ANMDMR: 20316/25
USER INFORMATION
Kit tuburi pentru oxigenator Hilite 7000 LT / manufacturer XENIOS AG, Germania
Ref. ANMDMR: 20325/25
USER INFORMATION
Medisa Automated Endoscope Reprocessors (AERs) / manufacturer Cantel Medical (Italy) S.r.l., Italia
Ref. ANMDMR: 20337/25
USER INFORMATION
4Fr Single Lumen PowerPICC / manufacturer Bard Access Systems, Inc, SUA
Ref. ANMDMR: 20339/25
USER INFORMATION
isla-cassis / manufacturer Engelhard Arzneimittel GmbH & Co. KG, Germania
Ref. ANMDMR: 20369/25
PRODUCT RECALL
Climber Guiding Catheter 5F EBU 3.5. / manufacturer PendraCare International B.V., Olanda
Ref. ANMDMR: 20370/25
USER INFORMATION
IntelliSpace Cardiovascular 7.0 / manufacturer Philips Medical Systems Nederland B.V., Olanda
Ref. ANMDMR: 20371/25
PRODUCT RECALL
Knieorthese ADVAGOknee / manufacturer OPED GmbH, Germania
Ref. ANMDMR: 20372/25
USER INFORMATION
VDR4 Phasitron Breathing Circuit Kit / manufacturer Percussionaire Corporation, SUA
Ref. ANMDMR: 20376/25
USER INFORMATION
Manusi examinare Halyard Purezero Limon/ manufacturer O&M Halyard, Inc., SUA
Ref. ANMDMR: 20381/25
USER INFORMATION
Rapid-VIDITEST Giardia / manufacturer VIDIA spol sro, Cehia
Ref. ANMDMR: 20386/25
USER INFORMATION
Actualizare la comunicarea GE HealthCare privind aparatele de anestezie Aisys CS2, Avance CS2, Avance CS2 Pro, Aisys, Avance, Amingo, Aespire 100, Aespire View, Aespire 7900 și Aespire 7100 echipate cu ieșire de gaz comună auxiliară / manufacturer Datex-Ohmeda, Inc., SUA
Ref. ANMDMR: 20388/25
USER INFORMATION
Sistem Philips DXR / manufacturer Philips Healthcare (Suzhou) Co., Ltd, China
Ref. ANMDMR: 20391/25
USER INFORMATION
Medistim L15 Ultrasound Imaging probe / manufacturer Medistim ASA, Norvegia
Ref. ANMDMR: 20406/25
USER INFORMATION
Single use endoscope cleaning brush / manufacturer LTA Medical (Getinge Company), Franța
Ref. ANMDMR: 20410/25
USER INFORMATION
Aortic Root Cannula included in Medline Sterile Procedure Trays / manufacturer Medline International France SAS, Franța
Ref. ANMDMR: 20412/25
USER INFORMATION
Sisteme RMN – Buton ”Start Scan” activ / manufacturer GE Healthcare (Tianjin) Company Limited, China
Ref. ANMDMR: 20413/25
USER INFORMATION
IRMA IGF-I / manufacturer IMMUNOTECH s.r.o, Cehia
Ref. ANMDMR: 20426/25
USER INFORMATION
Reactiv Inhibin B Gen II / manufacturer IMMUNOTECH s.r.o, Cehia
Ref. ANMDMR: 20429/25
USER INFORMATION
Reactiv kit IVD – Banda index A2 / manufacturer Devyser AB, Suedia
Ref. ANMDMR: 20442/25
USER INFORMATION
DeepUnity Viewer / manufacturer DH Healthcare GmbH, Germania
Ref. ANMDMR: 20456/25
PRODUCT RECALL
Catetere intratecale AscendaTM / manufacturer Medtronic Inc., SUA
Ref. ANMDMR: 20966/25
Please note: If you have questions regarding any of the aforementioned information, please contact the issuer of the field safety notification directly.