Recalls de dispositivos médicos da FDA
Recalls, correções e retiradas de dispositivos médicos mais recentes da FDA. Mantenha-se informado sobre questões de segurança.
Kits de Conveniência Medline contendo BD ChloraPrep Clear - Aplicadores de 1mL KIT DE CULTURA DE …
Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may have an open…
Ver recall da FDA →5008X Standard HD Pre-Flush Standard Blood Tubing Set Part Number 03-5110-6
Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line or pump segment. Leak during treatment may …
Ver recall da FDA →Philips Ingenuity CT Product Codes: Ingenuity CT Upgrades 728327, Ingenuity CT China 728324, Ing…
Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems that could affect the perform…
Ver recall da FDA →Velys Enabling Tech Robotic-Assist Station REF: 451611001
Software issue within robotic controller which may cause unintended movement of the robotic arm during bone preparation or instrument positioning.
Ver recall da FDA →Centricity PACS Server V7, intended for managing digital medical images and associated data, All ver…
Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occ…
Ver recall da FDA →MR 5300 Model Number (REF): 1. 782110, 2. 782152;
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstr…
Ver recall da FDA →Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Cod…
The potential for purge cassette recognition issues due to the failure of the purge flag component of the purge pressure sensor assembly.
Ver recall da FDA →GRANUFLO Dry Acid Concentrate: Product Numbers: 0FD2251-3B; 0FD3251-3B; Dry Acid Concentrate for B…
Complaints of blue-green discoloration in product
Ver recall da FDA →Products that contain the Pericare Wipes: SureStep" Foley Tray System Add-A-Foley Catheter REF: A15…
Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter…
Ver recall da FDA →Medline Convenience Kits: 1) DYKM1414, Catalog Number: DYKM1414; 2) DYKM1414, Catalog Number: DYK…
The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wri…
Ver recall da FDA →