SUMMARY OF FIELD SAFETY NOTIFICATIONS / FEBRUARY 2025
USER INFORMATION
Aplicație software Origin Data Management / manufacturer Brainlab AG, Germania
Ref. ANMDMR: 7986/25
USER INFORMATION
Idylla™ Instrument / manufacturer Biocartis NV, Belgia
Ref. ANMDMR: 7993/25
PRODUCT RECALL
Canulă pentru rădăcină aortică / manufacturer Medtronic, Inc., SUA
Ref. ANMDMR: 8009/25
PRODUCT RECALL
Control-A-Flo / manufacturer Baxter Healthcare SA, Elveția
Ref. ANMDMR: 8090/25
USER INFORMATION
ROTEM sigma complete / ROTEM sigma complete + hep / manufacturer Tem Innovations GmbH, Germania
Ref. ANMDMR: 8105/25
USER INFORMATION
Dexcom G6 Receiver / manufacturer Dexcom, Inc., SUA
Ref. ANMDMR: 9302/25
USER INFORMATION
Posibile scurgeri cauzate de fisuri – VentStar Flex 220, ID Circuit Flex 220, kit circuit de anestezie Flex / manufacturer Drägerwerk AG & Co. KGaA, Germania
Ref. ANMDMR: 11022/25
USER INFORMATION
Panel gastrointestinal (GI) Biofire® FILMARRAY® / manufacturer BioFire Diagnostics, LLC, SUA
Ref. ANMDMR: 11026/25
USER INFORMATION
Analizor de imunologie Access 2 / manufacturer Beckman Coulter, SUA
Ref. ANMDMR: 11283/25
USER INFORMATION
NEVELIA® / manufacturer SYMATESE, Franța
Ref. ANMDMR: 11312/25
USER INFORMATION
Origin Data Management / manufacturer Brainlab AG; Germania
Ref. ANMDMR: 11890/25
USER INFORMATION
ORBIS Medication 3.x / manufacturer DH Healthcare GmbH, Germania
Ref. ANMDMR: 11896/25
USER INFORMATION
Access Erythropoietin (EPO) / manufacturer Beckman Coulter Inc., SUA
Ref. ANMDMR: 11918/25
USER INFORMATION
Universal blood culture adapter, LongNeck blood culture adapter / manufacturer Sarstedt AG&Co.KG, Germania
Ref. ANMDMR: 12288/25
USER INFORMATION
Preparation unit PS-10 / manufacturer Sysmex Corporation Japan, Japonia
Ref. ANMDMR: 12290/25
USER INFORMATION
Anti-TPO / manufacturer ORGENTEC Diagnostika GmbH, Germania
Ref. ANMDMR: 12306/25
USER INFORMATION
Anti-TPO / manufacturer ORGENTEC Diagnostika GmbH,
Ref. ANMDMR: 12307/25
USER INFORMATION
Monitor funcții vitale pacienți- CMS6000/CMS6500/CMS7000
/CMS8000/CMS9000 / manufacturer Contec Medical Systems Co., Ltd., China
Ref. ANMDMR: 12674/25
USER INFORMATION
Monitor pacienți CMS8000 / manufacturer Contec Medical Systems Co., Ltd., China
Ref. ANMDMR: 12724/25
PRODUCT RECALL
Hamilton Medical In2Flow Nasal cannulas / manufacturer Hamilton Medical AG, Germania
Ref. ANMDMR: 12725/25
USER INFORMATION
Orthopilot® / manufacturer Aesculap AG, Germania
Ref. ANMDMR: 12728/25
USER INFORMATION
Vacuum Container / manufacturer Deltalab, S.L., Spania
Ref.: 25001/25
USER INFORMATION
Glucose liquicolor / manufacturer Human Gesellschaft für Biochemica und Diagnostica mbH, Germania
Ref.: 42662/24
USER INFORMATION
QIAsymphony DNA Midi Kit/ manufacturer QIAGEN GmbH, Germania
Ref.: 43973/25
USER INFORMATION
BlueDiver Dot Gastritis IgG / manufacturer D-Tek s.a, Belgia
Ref.: 2501131/25
USER INFORMATION
Medline’s Caresets and Sterile Procedure Trays / manufacturer Medline International France SAS, Franta
Ref.: 2501274/25
USER INFORMATION
ID DiaCell I-II-III / manufacturer DIAMED GmbH, Germania
Ref.: 2503616/25
PRODUCT RECALL
Precision Thin Blades / manufacturer Stryker Instruments, SUA
Ref. 3846155/25
USER INFORMATION
Stimulatoare cardiace Assurity™ și Endurity™ / manufacturer Abbott Medical, SUA
Ref: 125FA/25
USER INFORMATION
Linie de filtru CO2 intubată Microstream™ Advance pentru nou-născuți/sugari și adulți/copii,
Linie de filtru CO2 intubată Microstream™ Luer pentru adulți/copii și
Linie de eșantionare Microstream™ Luer cu adaptor pentru căile respiratorii pentru adulți/copii / manufacturer Covidien llc, SUA
Ref. : 1432
USER INFORMATION
IntelliBridge EC10 Module and IntelliBridge EC5 ID-Module Interfacing with driver
ED245 Hamilton Block (ACK) / manufacturer Philips Medizin Systeme Böblingen GmbH
Ref.: 01612/25
USER INFORMATION
Erori la sursa de alimentare neîntreruptibilă (UPS) a Patient Information Center (PIC) iX / manufacturer Philips Medical Systems, SUA
Ref.: 2024 010/25
USER INFORMATION
Manometre neautomatizate Welch Allyn / manufacturer Welch Allyn, Inc., SUA
Ref.: 2024. 071
PRODUCT RECALL
Laguna Bath Seat/ manufacturer RUSSKA – Ludwig Bertram GmbH, Germania
Ref.: 02127/25
PRODUCT RECALL
ColonicFTRD Set / manufacturer Ovesco Endoscopy AG, Germania
Ref. 02349/25
USER INFORMATION
Hamilton Medical Ventilators HAMILTON-C2/C3
with Neonatal Option / manufacturer
Ref. 02371/25
USER INFORMATION
Sondă endotraheală pentru intubație orală/nazală / manufacturer ICU Medical Inc, SUA
Ref. 002502-01/25
PRODUCT RECALL
APTUS Hand Plate / manufacturer Medartis AG, Germania
Ref.: 02738/25
USER INFORMATION
T2™ Rigid Reamers / manufacturer Stryker Trauma GmbH Kiel; Germania
Ref.: 03160/25
USER INFORMATION
Exelia software version / manufacturer Fresenius Kai AG, Germania
Ref.: 03254/25
USER INFORMATION
Medi stream 3000 water massage / manufacturer NM Stahlgeräte GmbH, Germania
Ref. 04143/25
PRODUCT RECALL
Climber Guiding Catheter / manufacturer PendraCare International B.V. Olanda
Ref.: 04823/25
USER INFORMATION
IntelliBridge EC10 Module / manufacturer Philips Medizin Systeme Böblingen GmbH, Germania
Ref. : 7359/25
Please note: If you have questions regarding any of the aforementioned information, please contact the issuer of the field safety notification directly.