Головна / Моніторинг Франція / Інформація, отримана з іноземних систем повідомлення про продукцію, що становить серйозний ризик, за період 01.01.2021 – 31.03.2021

Інформація, отримана з іноземних систем повідомлення про продукцію, що становить серйозний ризик, за період 01.01.2021 – 31.03.2021

Опубліковано 02.04.2021 о 17:09

https://ansm.sante.fr/S-informer/Informations-de-securite-Autres-mesures-de-securite

 

INFORMATION FOR USERS  MEDICAL DEVICES PUBLISHED ON 03/17/2021Ceiling mounted patient lift (rail) – Weighing systems for Maxi Sky 1000 and V10 – Arjo Huntleigh ABThe ANSM has been informed of the implementation of a safety action carried out by the company ARJO Huntleigh AB.

INFORMATION FOR USERS  IN VITRO DIAGNOSTIC MEDICAL DEVICES PUBLISHED ON 03/17/2021Automate – Cascadion SM Clinical Analyzer – Thermo Fischer Scientific OyThe ANSM has been informed of the implementation of a safety action carried out by the company Thermo Fischer Scientific Oy.

INFORMATION FOR USERS  MEDICAL DEVICES PUBLISHED ON 03/17/2021Practical kits and intervention sets containing BD syringes and needles – Merit MedicalANSM has been informed of the implementation of a safety action carried out by the company MERIT MEDICAL.

INFORMATION FOR USERS  MEDICAL DEVICES PUBLISHED ON 03/16/2021Synetic ophthalmic consultation unit – Nidek SAANSM has been informed of the implementation of a security action carried out by the company NIDEK SA

INFORMATION FOR USERS  MEDICAL DEVICES PUBLISHED ON 03/15/2021Waters and Digby Leigh valves from the manufacturer HAROL, TELEFLEX distributor: single-use devicesThe National Agency for Medicines and Health Products Safety (ANSM) recalls and confirms the conditions of use for Waters valves and DIGBY LEIGH valves, manufactured by HAROL and marketed in France by TELEFLEX.

INFORMATION FOR USERS  MEDICAL DEVICES PUBLISHED ON 03/15/2021External Defibrillator – Lifepak® CR2 Automated External Defibrillator – Physio-Control, Inc. (Stryker)External Defibrillator – Lifepak® CR2 Automated External Defibrillator – Physio-Control, Inc. (Stryker) – Safety Information

INFORMATION FOR USERS  MEDICAL DEVICES PUBLISHED ON 03/02/2021Custom Eyes and Malosa kits containing BD syringes and / or needles – BVICustom Eyes and Malosa kits containing BD syringes and / or needles – BVI – Safety information

INFORMATION FOR USERS  MEDICAL DEVICES PUBLISHED ON 03/02/2021External defibrillator – Fred Easyport plus -Schiller AGExternal defibrillator – Fred Easyport plus – Schiller AG – Safety information

INFORMATION FOR USERS  MEDICAL DEVICES PUBLISHED ON 03/26/2021Endoscope (accessory) – SHA-P6 Automatic Leak Tester – PENTAXSecurity information

INFORMATION FOR USERS  IN VITRO DIAGNOSTIC MEDICAL DEVICES PUBLISHED ON 03/26/2021Reagent – RAMP Cardiac Controls – Response BiomedicalSecurity information

INFORMATION FOR USERS  MEDICAL DEVICES PUBLISHED ON 03/26/2021Database on Medicines and Health Products – BCB, RESEARCH AND STUDIES IN PROFESSIONAL COMPUTER SYSTEMSLAP: prescription assistance software – Safety information

INFORMATION FOR USERS  MEDICAL DEVICES PUBLISHED ON 03/26/2021Syngo.via digital image processing system, SIEMENS HEALTHCARE SASSecurity information

INFORMATION FOR USERS  IN VITRO DIAGNOSTIC MEDICAL DEVICES PUBLISHED ON 03/26/2021ADVIA 2120 / 2120i Hematology System controllers – Siemens Healthcare DiagnosticsSecurity information

INFORMATION FOR USERS  MEDICAL DEVICES PUBLISHED ON 03/24/2021Heartware Ventricular Support: Power cables, monitor data cables and HVAD controller ports – HEARTWARE Inc. / MEDTRONICHeartware Ventricular Support: Power Cables, Monitor Data Cables, and HVAD Controller Ports – HEARTWARE Inc. / Medtronic – Safety Information

INFORMATION FOR USERS  MEDICAL DEVICES PUBLISHED ON 03/24/2021Orthopedics – Hip stems: Océane + / Meije Duo / Linea – Knee stems: HLS Noetos / HLS Kneetec – CorinThe ANSM has been informed of the implementation of a safety action carried out by the company Corin.

INFORMATION FOR USERS  MEDICAL DEVICES PUBLISHED ON 03/24/2021Relay Plus and Relay 85 thoracic endoprosthesis – BOLTON MEDICAL Inc / TERUMO AORTICRelay Plus and Relay 85 thoracic stent graft – Bolton Medical Inc / Terumo aortic – Safety information

 

INFORMATION FOR USERS  MEDICAL DEVICES PUBLISHED ON 03/24/2021Enteral nutrition pump tubing – CARDINAL HEALTHThe ANSM has been informed of the update (addition of product codes) of a security action carried out by the company Cardinal health.

INFORMATION FOR USERS  MEDICAL DEVICES PUBLISHED ON 03/23/2021CyberKnife radiotherapy machine – AccurayCyberKnife radiotherapy machine – Accuray – Safety information

INFORMATION FOR USERS  MEDICAL DEVICES PUBLISHED ON 03/23/2021BBraun syringes contained in ophthalmic kits Kitpacks / Raucosets LOHMANN & RAUSCHER INTERNATIONAL GMBH & CO KGBBraun syringes contained in ophthalmic kits Kitpacks / Raucosets LOHMANN & RAUSCHER INTERNATIONAL GMBH & CO KG – Safety information

INFORMATION FOR USERS  IN VITRO DIAGNOSTIC MEDICAL DEVICES PUBLISHED ON 03/22/2021T-Cell Select Reagent – Oxford ImmunotecT-Cell Select Reagent – Oxford Immunotec – Safety Information

INFORMATION FOR USERS  MEDICAL DEVICES PUBLISHED ON 03/19/2021Software radiotherapy – Raystation, Rayplan – RAYSEARCH LABORATORIESSoftware radiotherapy – Raystation, Rayplan – RAYSEARCH LABORATORIES – Safety information

INFORMATION FOR USERS  MEDICAL DEVICES PUBLISHED ON 03/19/2021Electrophysiology bay – Sensis, Sensis Vibe Combo, Sensis Vibe Hemo – SIEMENS HealthcareElectrophysiology bay – Sensis, Sensis Vibe Combo, Sensis Vibe Hemo – SIEMENS Healthcare – Safety information

INFORMATION FOR USERS  IN VITRO DIAGNOSTIC MEDICAL DEVICES PUBLISHED ON 03/19/2021I-Mag Screen Reagent – DIAGASTI-Mag Screen Reagent – DIAGAST – Safety information

INFORMATION FOR USERS  IN VITRO DIAGNOSTIC MEDICAL DEVICES PUBLISHED ON 03/19/2021Reagent ID- SARS-CoV-2 / UK / SA Variant Triplex – ID SOLUTIONSReagent ID- SARS-CoV-2 / UK / SA Variant Triplex – ID SOLUTIONS – Safety information

INFORMATION FOR USERS  MEDICAL DEVICES PUBLISHED ON 03/17/2021Synetic- Nidek SA ophthalmic consultation unitThe ANSM has been informed of the implementation of a security action carried out by the company NIDEK SA.

INFORMATION FOR USERS  MEDICAL DEVICES PUBLISHED ON 03/17/2021Magnus 1180 operating table abutment – Getinge / MaquetThe ANSM has been informed of the implementation of a safety action carried out by the company GETINGE / MAQUET.

INFORMATION FOR USERS  MEDICAL DEVICES PUBLISHED ON 03/17/2021BD Venflon ™ Pro Safety (VPS) Venous Catheter with Needle Safety System – Becton Dickinson Infusion Therapy ABThe ANSM has been informed of the implementation of a safety action carried out by the company BECTON DICKINSON INFUSION THERAPY AB.

INFORMATION FOR USERS  IN VITRO DIAGNOSTIC MEDICAL DEVICES PUBLISHED ON 03/17/2021Reagents ID-Card DiaClon Anti N & ID-Card Diaclon Anti-M / N – Bio-RadANSM has been informed of the implementation of a safety action carried out by the company BIO-RAD.

INFORMATION FOR USERS  MEDICAL DEVICES PUBLISHED ON 03/31/2021Implantable Neurostimulator – Intellis ™ Charger Model 97755, MEDTRONIC IncThe ANSM has been informed of the implementation of a safety action carried out by the company MEDTRONIC Inc.

INFORMATION FOR USERS  IN VITRO DIAGNOSTIC MEDICAL DEVICES PUBLISHED ON 03/31/2021Atellica COAG 360 PLC – Siemens Healthcare DiagnosticsThe ANSM has been informed of the implementation of a safety action carried out by the company Siemens Healthcare Diagnostics.

INFORMATION FOR USERS  MEDICAL DEVICES PUBLISHED ON 03/30/2021Doctor Programmer Model A610 App for Percept Deep Brain Stimulation – MEDTRONIC IncSafety information – Neurostimulator (accessory)

INFORMATION FOR USERS  MEDICAL DEVICES PUBLISHED ON 03/30/2021External CSF shunt device (accessory) – M. scio reader unit – Christoph Miethke GmbH & Co. KGSecurity information

INFORMATION FOR USERS  MEDICAL DEVICES PUBLISHED ON 03/29/2021Software (miscellaneous) – Centricity High Acuity Critical Care – Centricity Critical Care, GE HealthcareSecurity information

INFORMATION FOR USERS  MEDICAL DEVICES PUBLISHED ON 03/29/2021Implantable defibrillator – ICD and ICD triple chamber Idova, Iforia, Ilesto / Inventra, Iperia, Itrevia / Ilivia, Inlexa, Intica / Ilivia Neo and Intica Neo – Biotronik SE & CO. KGANSM has been informed of the implementation of a safety action carried out by the company BIOTRONIK SE & CO. KG.

INFORMATION FOR USERS  MEDICAL DEVICES PUBLISHED ON 03/29/2021Irrigation bags 3L VIAFLEX Glycine 1.5%, Sodium chloride 0.9%, Sterile water – BAXTERSecurity information

INFORMATION FOR USERS  IN VITRO DIAGNOSTIC MEDICAL DEVICES PUBLISHED ON 03/29/2021ORTHO VISION & ORTHO VISION Max PLCs – Ortho-Clinical DiagnosticsSecurity information

INFORMATION FOR USERS  MEDICAL DEVICES PUBLISHED ON 03/29/2021Transp and emergency ventilator – Medumat Transport – Weinmann Medical Technology -The ANSM has been informed of the implementation of a safety action carried out by the company Weinmann Medical Technology.

INFORMATION FOR USERS  IN VITRO DIAGNOSTIC MEDICAL DEVICES PUBLISHED ON 03/29/2021BCS XP System PLC – SiemensSecurity information

INFORMATION FOR USERS  MEDICAL DEVICES PUBLISHED ON 03/26/2021Closed Loop Insulin Delivery System – Software – MiniMed 780G Insulin Pump, MiniMed 670G Insulin Pump – Medtronic MiniMedSecurity information
* The associated file was updated on 03/30/2021

INFORMATION FOR USERS  MEDICAL DEVICES PUBLISHED ON 03/26/2021Intra-Aortic Counterpulse Console / CPIA- Cardiosave Hybrid and Rescue CS100, CS300 Intra-Aortic Balloon Pumps, Intra-aortic Counterpulse Consoles (CPBIA) – Datascope CORP. (Getinge)Security information

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