SUMMARY OF FIELD SAFETY NOTIFICATIONS / JUNE 2025
USER INFORMATION
Dexcom One, Dexcom G7 and Dexcom One+ Receivers / manufacturer Dexcom, Inc. SUA
Ref. ANMDMR: 411/25
PRODUCT RECALL
Lifepearl™ Drug Elutable Microspheres / manufacturer MicroVention Europe SARL, Franta
Ref. ANMDMR: 495/25
USER INFORMATION
BD FACS Mărgele™ de configurare în 7 culori / manufacturer Becton, Dickinson and Company, SUA
Ref. ANMDMR: 496/25
USER INFORMATION
Dexcom G7 iOS App version 2.7 / manufacturer Dexcom, Inc., SUA
Ref. ANMDMR: 497/25
PRODUCT RECALL
Sistem de dezinfectare cu peroxid 3% pentru lentile de contact / manufacturer DISOP S.A., Spania
Ref. ANMDMR: 504/25
USER INFORMATION
Consumabile produse de MEDTRON AG / manufacturer MEDTRON AG, Germania
Ref. ANMDMR: 506/25
USER INFORMATION
Sisteme cu ultrasunete: Versana Premier / LOGIQ F seria R3 / manufacturer GE Medical Systems (China) Co., Ltd., China
Ref. ANMDMR: 508/25
USER INFORMATION
Sistem Uroskop Omnia / Omnia Max / manufacturer Siemens Healthcare GmbH, Germania
Ref. ANMDMR: 509/25
USER INFORMATION
Filtre/HME Dräger SafeStar Plus, TwinStar HEPA Plus / manufacturer Drägerwerk AG & Co. KGaA, Germania
Ref. ANMDMR: 510/25
USER INFORMATION
Copeland® Fetal Scalp Electrode / manufacturer Rocket Medical PLC, Marea Britanie
REF. ANMDMR: 511/25
USER INFORMATION
ORBIS Medication 3.x / manufacturer DH Healthcare GmbH, Germania
Ref. ANMDMR: 512/25
USER INFORMATION
Synapse PACS 7.4.x / manufacturer FUJIFILM Healthcare Americas Corporation
Ref. ANMDMR: 513/25
USER INFORMATION
Soltive Laser System / manufacturer Gyrus ACMI, Inc. (Olympus Surgical Technologies America), SUA
Ref. ANMDMR: 514/25
PRODUCT RECALL
Liaison® Biotrin Parvovirus B19 IgM / manufacturer Diasorin Italia S.p.A., Italia
Ref. ANMDMR: 515/25
USER INFORMATION
BIOFIRE BCID2 Panel / manufacturer BioFire Diagnostics, LLC, SUA
Ref. ANMDMR: 516/25
USER INFORMATION
ORBIS Medication 3.x / manufacturer DH Healthcare GmbH, Germania
Ref. ANMDMR: 517/25
USER INFORMATION
Sisteme Philips Azurion R1.x și R2.x / manufacturer Philips Medical Systems Nederland BV, Tările de Jos
Ref. ANMDMR: 522/25
USER INFORMATION
DeepUnity PACSonWEB / manufacturer DH Healthcare GmbH, Germania
Ref. ANMDMR: 524/25
PRODUCT RECALL
Impactor, iliac peg / manufacturer Peter Brehm GmbH, Germania
Ref. ANMDMR: 526/25
PRODUCT RECALL
Canulă arterială / manufacturer Edwards Lifesciences LLC, SUA
Ref. ANMDMR: 527/25
PRODUCT RECALL
iGo2-125 Series Portable Oxygen Concentrator / manufacturer DeVilbiss Healthcare LLC, SUA
Ref. ANMDMR: 530/25
USER INFORMATION
Pinnacle Radiation Therapy Planning System / manufacturer Philips Medical Systems (Cleveland), Inc., SUA
Ref. ANMDMR: 531/25
PRODUCT RECALL
One-piece Guedel airways / manufacturer IntersurgicaL Ltd., Marea Britanie
Ref. ANMDMR: 532/25
USER INFORMATION
Duodenoscop / manufacturer Olympus Medical Systems Corporation, Japonia
Ref. ANMDMR: 533/25
PRODUCT RECALL
EmboLog S 450 mg / manufacturer Serumwerk Bernburg AG, Germania
Ref. ANMDMR: 540/25
USER INFORMATION
Cateter IVUS digital / manufacturer Philips (Volcano Corporation), SUA
Ref. ANMDMR: 541/25
PRODUCT RECALL
HeartSine samaritan® PAD 350P/360P/450P/500P / manufacturer Medical (Heartsine Technologies Ltd.), Marea Britanie
Ref. ANMDMR: 542/25
PRODUCT RECALL
OptiSite Arterial Cannula, Femoral Arterial Cannula / manufacturer Edwards Lifesciences LLC, SUA
Ref. ANMDMR: 543/25
USER INFORMATION
Actualizare software: Medtronic CareLink™ SmartSync™ / manufacturer Medtronic Inc., SUA
Ref. ANMDMR: 544/25
USER INFORMATION
VIDAS® HIV DUO AG/AB / manufacturer bioMérieux SA, SUA
Ref. ANMDMR: 545/25
USER INFORMATION
Actualizare software: Medtronic CareLink™ SmartSync™ / manufacturer Medtronic Inc., SUA
Ref. ANMDMR: 546/25
PRODUCT RECALL
Y-Piece Breathing Trainers / manufacturer Flexicare Medical LTD, Marea Britanie
Ref. ANMDMR: 547/25
USER INFORMATION
mRay / manufacturer mbits imaging GmbH, Germania
Ref. ANMDMR: 548/25
USER INFORMATION
aPTT Screen cobas t 600T, aPTT Lupus cobas t 600T, aPTT cobas t 600T / manufacturer Roche Diagnostics GmbH, Germania
Ref. ANMDMR: 549/25
USER INFORMATION
Sisteme RMN : Vantage Orian MRT-1550, Vantage Elan MRT-2020, Vantage Titan MRT-1504 / manufacturer Canon Medical Systems Corporation, Japonia
Ref. ANMDMR: 550/25
PRODUCT RECALL
Sistem mobil de ridicare a pacienților: Uno 102 EE, LikoLight, LikoScale and Viking XL/L/M Mobile Lift / manufacturer Liko AB, Suedia
Ref. ANMDMR: 551/25
USER INFORMATION
InPen Application App / manufacturer Medtronic Minimed, SUA
Ref. ANMDMR: 552/25
USER INFORMATION
Sprinter Cart (XL) / manufacturer Maquet Cardiopulmonary GmbH, Germania
Ref. ANMDMR: 560/25
USER INFORMATION
Nellcor Bedside SpO2 Patient Monitoring System / manufacturer Covidien LLC, SUA
Ref. ANMDMR: 561/25
USER INFORMATION
ORBIS Medication 3.x / manufacturer DH Healthcare GmbH, Germania
Ref. ANMDMR: 562/25
USER INFORMATION
Dispozitivele Gelsoft Plus și Gelweave / manufacturer Vascutek Ltd, Marea Britanie
Ref. ANMDMR: 563/25
USER INFORMATION
Datascope Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps (IABP) / manufacturer AGA Sanitätsartikel GmbH, Germania
Ref. ANMDMR: 564/25
USER INFORMATION
Pompă de nutriție enterală: Easymoov6 / manufacturer MEDWIN FRANCE, Franța
Ref. ANMDMR: 565/25
USER INFORMATION
Sheath, 20Fr / manufacturer Trokamed GmbH, Germania
Ref. ANMDMR: 566/25
USER INFORMATION
3mensio Workstation / manufacturer Pie Medical Imaging B.V., Olanda
Ref. ANMDMR: 574/25
USER INFORMATION
Polycentric 4 BAR Manual Locking Knee / manufacturer Regal Prosthesis Ltd, China
Ref. ANMDMR: 575/25
PRODUCT RECALL
NIO lntraosseous Device Adult / manufacturer Waismed ltd., Israel
Ref. ANMDMR: 588/25
Please note: If you have questions regarding any of the aforementioned information, please contact the issuer of the field safety notification directly.