Tecnología Médica

Tecnología Médica

El Organismo Notificado 0318 certifica un total de 40 productos sanitarios en 2021
23/09/2022 - El Organismo Notificado 0318, encargado de certificar los productos sanitarios en España, emitió un total de 40 certificados en 2021 de acuerdo a la ya...
FDA Roundup: September 20, 2022
22/09/2022 - FDA Roundup: September 20, 2022
Alerta 3952 (Tecnovigilância)
21/09/2022 - Comunicado da empresa Cmos Drake do Nordeste S.A - Desfibrilador Life 400 Futura - Comunicação de Usabilidade para o consumidor final.
Alerta 3951 (Tecnovigilância)
21/09/2022 - Comunicado da empresa Getinge do Brasil Equipamentos Médicos Ltda - Cateter Balão Intra-Aórtico – Recolhimento – Devolução ao fabricante.
Update: Recommendations for Certain Medtronic Electromyogram Endotracheal Tubes and Risk of Airway Obstruction – Letter to Health Care Providers
19/09/2022 - Medtronic initiates recall for silicone-based EMG endotracheal tubes due to the risk of airway obstruction and ventilation failure.
Alerta 3950 (Tecnovigilância)
19/09/2022 - Comunicado da empresa Stryker do Brasil LTDA - Cateter Guia Guider Softip. Recolhimento. Devolução para o fabricante.
Respironics Masks
19/09/2022 - The affected masks contain magnets which can potentially affect the functioning and/or induce the movement/dislocation of medical implants or medical devices that can be impacted by the magnetic...
FDA Roundup: September 16, 2022
19/09/2022 - FDA Roundup: September 16, 2022
Baxter Healthcare Corporation Recalls Clearlink Basic Solution Set with Duovent for Risk of Leaks That May Expose Providers and Patients to Hazardous / Toxic Substances
16/09/2022 - The Clearlink Basic Solution Set with Duovent may begin to leak, which poses risk of serious injury or death.
Ent-Single-Use Suction Tube
15/09/2022 - The rounded tip can detach from the shaft which could be left behind in the the treated area or aspirated. Recall start date: September 7, 2022
Disposición N° 7079/2022
15/09/2022 - Prohibese el uso, comercialización y distribución en todo el territorio nacional de todos los lotes del producto identificado como “Silvernail Implantes RB S.R.L. COLUMNA,...
MDCG 2022-15 - Guidance on appropriate surveillance regarding the transitional provisions under Article 110 of the IVDR (September 2022)
15/09/2022 - This guidance document outlines the activities to be performed by notified bodies7 as part of the appropriate surveillance defined in Article 110(3) last subparagraph IVDR. To clarify elements to...
MDCG 2021-22 rev.1 - Clarification on “first certification for that type of device” and corresponding procedures to be followed by notified bodies (September 2022)
15/09/2022 - This document has been endorsed by the Medical Device Coordination Group (MDCG) established by Article 103 of Regulation (EU) 2017/745. The MDCG is composed of representatives of all Member States...
FDA Roundup: September 13, 2022
14/09/2022 - FDA Roundup: September 13, 2022
FDA Roundup: September 9, 2022
12/09/2022 - FDA Roundup: September 9, 2022
Abbott MitraClip Device: Potential for Clip Lock Malfunctions – Letter to Health Care Providers
12/09/2022 - There are reports of clip lock malfunctions before and after clip deployment with the Abbott MitraClip device.
K360 Scalpel Handle
09/09/2022 - Hu-Friedy has identified that the scalpel holder )tip/head of the device) may separate from the handle for certain lots of K360 Scalpel Handles. Should the tip fall off during use, it could fall into...
Abbott MitraClip Device: Potential for Clip Lock Malfunctions – Letter to Health Care Providers
09/09/2022 - There are reports of clip lock malfunctions before and after clip deployment with the Abbott MitraClip device.
Power Knee
09/09/2022 - Össur received reports of a small number of units where the battery dislodged from the power knee unit, causing loss of power to the device. The decision to conduct a medical device...
Fep Introcan Safety IV Catheter - Straight (No Wings)
09/09/2022 - Investigation conducted at the manufacturing site identified deviations at the catheter hub that could lead to leakage of the product. Recall start date: August 25, 2022
Breast Implants: Reports of Squamous Cell Carcinoma and Various Lymphomas in Capsule Around Implants: FDA Safety Communication
09/09/2022 - Reports of squamous cell carcinoma and various lymphomas in capsule around breast implants. Read recommendations for patients and health care providers