SUMMARY OF FIELD SAFETY NOTIFICATIONS / SEPTEMBER 2024
USER INFORMATION
Tub de traheotomie din PVC siliconizat Portex ™ Blue Line / manufacturer Smiths Medical ASD Inc., SUA
Ref. ANMDMR: 302.423c/24
USER INFORMATION
Dispozitiv de calibrare HbA1c II / manufacturer Randox Laboratories Ltd, Regatul Unit
Ref. ANMDMR: 302.984/24
USER INFORMATION
Videolaringoscop McGRATH™ MAC / manufacturer Covidien LLC, SUA
Ref. ANMDMR: 304.825c/24
USER INFORMATION
High flow insufflation unit / manufacturer Olympus Medical Systems Corporation, Japonia
Ref. ANMDMR: 305.390/24
PRODUCT RECALL
General Hip Instruments / manufacturer Waldemar Link GmbH & Co. KG, Germania
Ref. ANMDMR: 305.391/24
PRODUCT RECALL
Custom Tubing Set with Softline coating / manufacturer Maquet Cardiopulmonary GmbH, Germania
Ref. ANMDMR: 305.392/24
USER INFORMATION
Baterie corpuls cpr (LiPo) / manufacturer GS Elektromedizinische Geräte G. Stemple GmbH, Germania
Ref. ANMDMR: 305.415/24
USER INFORMATION
Formaldehyde solution / manufacturer SAV Liquid Production GmbH, Germania
Ref. ANMDMR: 305.430/24
USER INFORMATION
Software application: Enterprise Imaging XERO Viewer / manufacturer Agfa HealthCare NV, Belgia
Ref. ANMDMR: 305.434/24
USER INFORMATION
Patient data management system: M-PDMS / manufacturer Meierhofer Medizintechnik GmbH, Germania
Ref. ANMDMR: 305.435/24
USER INFORMATION
Loss of image data in DeepUnity DICOM Services / manufacturer DH Healthcare GmbH, Germania
Ref. ANMDMR: 305.439/24
USER INFORMATION
Stolen ophthalmic medical devices: MR Q SLT model s/ manufacturer Meridian Medical d.o.o., Slovenia
Ref. ANMDMR: 305.475/24
USER INFORMATION
Olympus SOLTIVE SuperPulsed Laser System / manufacturer Gyrus ACMI, Inc. (Olympus Surgical Technologies America), SUA
Ref. ANMDMR: 305.651/24
USER INFORMATION
Software versions of X-ray TV system: SONIALVISION G4 / FLUOROspeed / manufacturer SHIMADZU Corporation, Japonia
Ref. ANMDMR: 305.674/24
USER INFORMATION
Cryostat devices :Leica CM1950, Leica CM3050 S, Leica CM3050 S, Leica CM1850 UV, Leica CM1850 UV, Leica CM1850, Leica CM1510 S, Leica CM1100, Leica CM1500, Leica CM1800, Leica CM1900, Leica CM1900 UV, Leica CM3000, Leica CM3050 / manufacturer Leica Biosystems Nussloch GmbH, Germania
Ref. ANMDMR: 305.676/24
USER INFORMATION
MEERA-table controlled via an IR-Hand Control / manufacturer MAQUET GmbH, Germania
Ref. ANMDMR: 305.691/24
USER INFORMATION
Olympus EVIS EXERA™ III GIF-H190N Gastrointestinal Videoscope, Olympus EVIS X1™ GIF-1100
Gastrointestinal Videoscope, Olympus EVIS X1 BF-H1100 and BF-1TH1100 Bronchovideoscopes, and Olympus EVIS EXERA III SIF-H190 Small Intestinal Videoscope/ manufacturer Olympus Medical Systems Corporation, Japonia
Ref. ANMDMR: 305.696/24
PRODUCT RECALL
BIOLOX® delta cup insert Ø 32/44mm / manufacturer implantcast GmbH, Germania
Ref. ANMDMR: 305.699/24
USER INFORMATION
Alinity m HR HPV AMP Kit & Alinity m STI AMP Kit utilized with Alinity m System / manufacturer Abbott Molecular, Inc., SUA
Ref. ANMDMR: 305.705/24
USER INFORMATION
Olympus OFP-2 Flushing Pump / manufacturer Olympus KeyMed, Marea Britanie
Ref. ANMDMR: 305.731/24
USER INFORMATION
Volumetric Pump: ARGUS 717V and ARGUS 718V / manufacturer CODAN ARGUS AG, Elveția
Ref. ANMDMR: 305.734/24
USER INFORMATION
Shimadzu Digital Angiography System: Trinias (System with KS-100) / manufacturer SHIMADZU Corporation, Japonia
Ref. ANMDMR: 305.785/24
USER INFORMATION
Sistemele Philips Azurion și Allura Xper, Integris şi MultiDiagnost Eleva/ manufacturer Philips Medical Systems Nederland BV, Olanda
Ref. ANMDMR: 305.792/24
USER INFORMATION
SIL-20ACXR CL, SIL-20ACHT CL, SIL-30AC CL / manufacturer SHIMADZU Corporation, Japonia
Ref. ANMDMR: 305.794/24
USER INFORMATION
SIL-40C XR CL, SIL-40C X3 CL / manufacturer SHIMADZU Corporation, Japonia
Ref. ANMDMR: 305.795/24
USER INFORMATION
Reusable Flow Sensor and Single Use Flow Sensor / producător SLE Ltd, Regatul Unit
Ref. ANMDMR: 305.797/24
PRODUCT RECALL
Synthetic bone defect filler GUIDOR® easy-graft® CRYSTAL / manufacturer Degradable Solutions, Elveția
Ref. ANMDMR: 305.799/24
USER INFORMATION
Actualizare librarie teste pentru analizoare de coagulare ACL Elite/ Elite Pro / manufacturer Instrumentation Laboratory Co., SUA
Ref. ANMDMR: 305.859/24
USER INFORMATION
QualityMix Flowmeter / Quality Flowmeter / manufacturer DEHAS Medical Systems GmbH, Germania
Ref. ANMDMR: 305.927/24
USER INFORMATION
Suport pentru pacient sistem RM / manufacturer Philips Medical Systems Nederland B.V., Olanda
Ref. ANMDMR: 305.934/24
USER INFORMATION
Blueflow Venous Stent / manufacturer Contract Medical International GmbH, Germania
Ref. ANMDMR: 305.936/24
USER INFORMATION
Spaceplus Perfusor® with Take Over Mode (TOM) / manufacturer B.Braun Melsungen AG, Germania
Ref. ANMDMR: 305.939/24
USER INFORMATION
Sisteme cu ultrasunete ACUSON Maple si ACUSON Maple Select / manufacturer Siemens Medical Solutions USA, Inc. Ultrasound, SUA
Ref. ANMDMR: 306.237/24
USER INFORMATION
Sisteme cu ultrasunete ACUSON Redwood 1,0 / manufacturer Siemens Medical Solutions USA, Inc. Ultrasound, SUA
Ref. ANMDMR: 306.240/24
USER INFORMATION
Sisteme cu ultrasunete ACUSON Juniper și ACUSON Juniper Select/ manufacturer Siemens Medical Solutions USA, Inc. Ultrasound, SUA
Ref. ANMDMR: 306.246/24
USER INFORMATION
Sisteme cu ultrasunete ACUSON Redwood / manufacturer Siemens Medical Solutions USA, Inc. Ultrasound, SUA
Ref. ANMDMR: 306.247/24
USER INFORMATION
Sisteme cu ultrasunete ACUSON Juniper si ACUSON Maple / manufacturer Siemens Medical Solutions USA, Inc. Ultrasound, SUA
Ref. ANMDMR: 306.248/24
Please note: If you have questions regarding any of the aforementioned information, please contact the issuer of the field safety notification directly.