Tecnología Médica

Tecnología Médica

IMPRESCINDIBLE

Remanufacturing of Medical Devices

13/05/2024 - This final guidance is intended to help clarify whether activities performed on devices are likely “remanufacturing.” This final guidance also clarifies existing regulatory requirements for remanufacturers and includes recommendations for information that should be included in labeling to help assure the continued quality, safety, and effectiveness of devices that are intended to be serviced over their useful life.

IMPRESCINDIBLE

ANMAT advierte sobre unidades falsificadas de Implantes RB SRL- Tornillo de interferencia p/LCA. TI

15/05/2024 - ANMAT informa que durante la fiscalización de rutina en un establecimiento distribuidor de productos médicos, se han detectado unidades falsificadas de un tornillo de interferencia identificado como Implantes RB SRL- Tornillo de interferencia p/LCA. TI.

Alerta 4485 (Tecnovigilância) - Comunicado da empresa Ventura Biomédica Ltda - Conjunto de Cateter de Drenagem Externa Lombar.
16/05/2024 - Foi identificado erro na tampografia do componente cateter lombar. Este item é pertencente ao kit do produto Conjunto de Cateter de Drenagem Externa Lombar, registro ANVISA n°.:...
Synchro Guidewires
16/05/2024 - Stryker Neurovascular has observed an increased frequency of PTFE coating damage occurring on the Synchro Guidewires that may be caused by the practice of backloading the guidewire through the...
Mega Soft Universal Patient Return Electrode
16/05/2024 - Megadyne has received reports of patient burn injuries in procedures where the Mega Soft Patient Return Electrodes were used.  A root cause investigation on the reports included testing which...
Alerta 4482 (Tecnovigilância) - Comunicado da empresa Ortocir Ortopedia Cirurgia Ltda - Família de Cages em Peek por Via Posterior - Medicrea.
14/05/2024 - A embalagem estéril pode não estar em conformidade com as especificações da Medtronic. Os produtos da Medicrea são embalados em um sistema de embalagem...
Alerta 4481 (Tecnovigilância) - Comunicado da empresa Blumenthal Distribuidora - Importação, Exportação, Comércio e Distribuição de Materiais Médico-Hospitalares e Ortopédicos Ltda - Rheo Knee; Rheo Knee XC.
14/05/2024 - Foi detectado um defeito na versão BRK3.02.17 do firmware dos dispositivos Rheo Knee e Rheo Knee XC que está provocando avisos inesperados nos dispositivos (luz vermelha...
Alerta 4480 (Tecnovigilância) - Comunicado da empresa Víncula Indústria Comércio Importação Exportação Implantes S.A - Substituto ósseo injetável n-ibs.
13/05/2024 - Publicação, em 29/01/2024, da RE n. 315 de 25 de janeiro de 2024, determinando o cancelamento do registro do produto. Cancelamento teve como origem uma reavaliação do...
Alerta 4479 (Tecnovigilância) - Comunicado da empresa Stryker do Brasil Ltda - Kit de Instrumentais Descartáveis Mica.
13/05/2024 - A Stryker identificou uma não conformidade em lotes específicos do Kit de Instrumentais Descartáveis Mica. O Kit de Instrumentais Descartáveis Mica não aperta a...
Luer Slip and Luer Lock Syringes
10/05/2024 - It has been identified that testing documentation does not support that the syringes can successfully deliver accurate volumes across the full range of their claimed graduated capacity and may...
MED-RX® Epidural Anesthesia Kit
10/05/2024 - The depth markers on the epidural catheter have potential to fade or wear away during product use. This issue could create a delay in procedure, as it may prevent anesthesiologists from accurately...
Stryker ProCuity Beds
09/05/2024 - Stryker has identified that the manufacturing records for certain ProCuity beds are missing test values for electrical safety tests as required by IEC 62353:2014. As a result of the missing test...
Alcon Ophthalmic Knife
09/05/2024 - On April 24, 2024 Alcon Canada was notified of an increase in customer reports of dull or knife not sharp for specific Clearcut® Dual Bevel Sideport and A-OK® Corneal/Scleral V-lance...
Integra Cranial Kit
09/05/2024 - The decision to conduct a voluntary removal of the product was based on the following: through an internal investigation, it was identified that there is a defect (potential holes and tears) in...
Medline Control Syringe Fixed Male Luer Lock
08/05/2024 - Recall action follows a United States Food and Drug Administration safety alert dated March 19, 2024, which identified potential issues with these products, including leaks, breakage, and other...
Ultra Intra-Aortic Balloon Pumps (IABP)
08/05/2024 - Teleflex is initiating this voluntary correction for the above-mentioned products due to reports indicating an infrequent condition that, when not identified and corrected promptly, could result...
Alerta 4476 (Tecnovigilância) - Comunicado da empresa Zimmer Biomet Brasil Ltda - Sistema de Placas Bloqueadas e Parafusos para Mini e Micro Fragmentos Zimmer.
07/05/2024 - A Zimmer Biomet Brasil está conduzindo um recall de dispositivo médico de lote específico dos produtos de Sistema de placa de fixação periarticular Zimmer® e...
CARESCAPE Monitoring System
07/05/2024 - Potential for loss of monitoring if, following the replacement of the CPU timekeeper battery, a mains power loss occurs during active monitoring. Recall start date: April 22, 2024
Incisive CT System
07/05/2024 - Philips has identified a hardware issue with a metal mounting box on the rotating scanner on rotor (heat change box) located within the Incisive CT system. The component's structural integrity...
SYNCHRONY 2 Cochlear Implant
07/05/2024 - MED-EL has recently identified a small number of devices, which may have a higher probability of a crack within the internal electronics substrate which could result in a non-functional...
EsoFLIP Dilation Catheter 30mm
06/05/2024 - Medtronic has received complaints of ES-330 catheters measuring diameters that are significantly (more than 50%) lower than actual. The failure mode may be reported as "failed precheck",...