SUMMARY OF FIELD SAFETY NOTIFICATIONS / NOVEMBER 2024
USER INFORMATION
Conexiunile terminalelor sistemelor RM în unitatea generală de distribuţie a reţelei/ manufacturer Philips Medical Systems Nederland B.V., China
Ref. ANMDMR: 303.008/24
USER INFORMATION
Masă chirurgicală de precizie PST 500 U/ manufacturer Baxter Medical Systems GmbH + Co. KG, Germania
Ref. ANMDMR: 304.133/24
USER INFORMATION
Actualizare privind lansarea soluţiei software / manufacturer Philips Goldway (Shenzhen) Industrial Inc., China
Ref. ANMDMR: 304.872/24
USER INFORMATION
Masă de operație: TruSystem 7000/ manufacturer Baxter Medical Systems GmbH + Co. KG, Germania
Ref. ANMDMR: 305.990/24
USER INFORMATION
VIDAS® CK-MB / manufacturer bioMérieux SA, Franța
Ref. ANMDMR: 306.152/24
USER INFORMATION
Lămpi chirurgicale Merivaara Q-Flow/ manufacturer Merivaara Corporation, Finlanda
Ref. ANMDMR: 306.216/24
USER INFORMATION
Catetere PowerPICCsingle lumen 4Fr / manufacturer Bard Access Systems, Inc, SUA
Ref. ANMDMR: 306.695/24
USER INFORMATION
BD BACTEC™ Blood Culture System, BD Phoenix™ M50 Automated
Microbiology System, BD MAX™ System, BD COR™ System, BD EpiCenter™ Microbiology Data
Management System, BD Synapsys™ Informatics Solution / manufacturer Becton, Dickinson and Company, SUA
Ref. ANMDMR: 306.735/24
PRODUCT RECALL
SELUTION SLR™ 018 PTA 3.0mm X 100mm Balloon Catheters/ manufacturer M.A. Med Alliance SA (MedAlliance), Elveția
Ref. ANMDMR: 306.766/24
PRODUCT RECALL
Lovo and Lovo Med Cell Processing System Primary Kits / manufacturer Fresenius Kabi AG, Germania
Ref. ANMDMR: 306.819/24
USER INFORMATION
MiniCap Extended Life PD transfer / manufacturer Baxter Healthcare SA, Elveția
Ref. ANMDMR: 306.820/24
USER INFORMATION
RocheDiabetes® Care Platform / Accu-Chek® Care / manufacturer Roche Diabetes Care GmbH, Germania
Ref. ANMDMR: 306.821/24
USER INFORMATION
Sisteme externe de drenaj și monitorizare (EDMS) Becker și Exacta/ manufacturer Medtronic Inc., SUA
Ref. ANMDMR: 306.822/24
USER INFORMATION
ACURATE neo2TM and ACURATE PrimeTM Aortic Valve Systems/ manufacturer Boston Scientific Corporation, SUA
Ref. ANMDMR: 306.823/24
USER INFORMATION
Homocysteine Enzymatic Assay/ manufacturer Roche Diagnostics GmbH, Germania
Ref. ANMDMR: 306.860/24
USER INFORMATION
ID MEDICS / manufacturer ID GmbH & Co. KGaA, Germania
Ref. ANMDMR: 306.861/24
USER INFORMATION
Radiology software: mint lesion / manufacturer Mint Medical GmbH, Germania
Ref. ANMDMR: 306.862/24
USER INFORMATION
WEINMANN MEDUMAT Transport and MEDUMAT Standard² ventilators with CO2 measurement / manufacturer WEINMANN Emergency Medical Technology GmbH+Co.KG, Germania
Ref. ANMDMR: 306.883/24
USER INFORMATION
Sisteme Proteus XR/a / manufacturer GE Medical Systems SCS, Franta
Ref. ANMDMR: 306.884/24
USER INFORMATION
Substrat Access / manufacturer Beckman Coulter, SUA
Ref. ANMDMR: 306.894/24
USER INFORMATION
Actualizare instrucțiuni de utilizare dispozitiv Thoraflex Hybrid / manufacturer Vascutek Ltd, Marea Britanie
Ref. ANMDMR: 306.922/24
PRODUCT RECALL
DFH-1028, Handle Assy, Single-Use/ manufacturer MicroSurgical Technology, Inc., SUA
Ref. ANMDMR: 306.936/24
PRODUCT RECALL
ELUTION SLRTM 018 PTA 3.00 mm × 100 mm Balloon Catheter/ manufacturer M.A. Med Alliance SA (MedAlliance), Elveția
Ref. ANMDMR: 307.019/24
USER INFORMATION
Sistem de plasmafereză Aurora / manufacturer Fresenius Kabi AG, Germania
Ref. ANMDMR: 307.020/24
USER INFORMATION
Essenz Heart-Lung Machine (HLM) with Software Version HLM.1.5 / manufacturer LivaNova Deutschland GmbH, Germania
Ref. ANMDMR: 307.027/24
USER INFORMATION
Olympus OFP-2 Flushing Pump / manufacturer Olympus KeyMed, Marea Britanie
Ref. ANMDMR: 307.028/24
USER INFORMATION
MEDUMAT Standard 2 with CO2 measurement, emergency and transport ventilator / manufacturer WEINMANN Emergency Medical Technology GmbH + Co. KG, Germania
Ref. ANMDMR: 307.055/24
USER INFORMATION
Aplicația software SynchroMed™ A810 de programare pentru clinician v2.x. / manufacturer Medtronic, Inc., SUA
Ref. ANMDMR: 307.129/24
PRODUCT RECALL
BIORAPTOR PK Suture Anchors / manufacturer Smith & Nephew, Inc., SUA
Ref. ANMDMR: 307.130/24
USER INFORMATION
Citometru în flux BD FACSLyric™ / manufacturer Becton, Dickinson and Company, SUA
Ref. ANMDMR: 307.131/24
USER INFORMATION
Kit de reactivi hsTnI Access / manufacturer Immunotech S.A.S., Franța
Ref. ANMDMR: 307.167/24
PRODUCT RECALL
Accu-Chek® Spirit 3.15 ml cartridge system: Potential of insulin leakage / manufacturer Roche Diabetes Care GmbH, Germania
Ref. ANMDMR: 307.171/24
USER INFORMATION
Ophthalmic Viscosurgical Device (OVD) / manufacturer Hyaltech Ltd, Marea Britanie
Ref. ANMDMR: 307.175/24
USER INFORMATION
VIDAS® CK-MB / manufacturer bioMérieux, Franta
Ref. ANMDMR: 307.270/24
USER INFORMATION
Bobine pentru sân sistem RM Philips / manufacturer Philips Healthcare, Olanda
Ref. ANMDMR: 307.271/24
USER INFORMATION
Inspection and Cleaning of pump exterior components in Aurora Plasmapheresis
System / manufacturer Fresenius Kabi AG, Germania
Ref. ANMDMR: 307.274/24
PRODUCT RECALL
Vacuum mixer for vertebroplasty cements: Synimix / manufacturer Synergie Ingénierie Medicale, Franta
Ref. ANMDMR: 307.277/24
USER INFORMATION
Battery corpuls aed / manufacturer GS Elektromedizinische Geräte G. Stemple GmbH, Germania
Ref. ANMDMR: 307.358/24
USER INFORMATION
Arthrex SynergyRF System / manufacturer Arthrex INC, SUA
Ref. ANMDMR: 307.362/24
Please note: If you have questions regarding any of the aforementioned information, please contact the issuer of the field safety notification directly.