FDA 医疗器械召回
FDA 最新医疗器械召回、纠正和移除信息。及时了解影响医疗器械的安全问题。
Medline方便套件包含BD ChloraPrep Clear - 1mL 涂抹器 成人血液培养套件 DYNDH1444D 血液培养套件变体装置 DYNDH1866 血…
Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may have an open…
查看 FDA 召回 →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 …
查看 FDA 召回 →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…
查看 FDA 召回 →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.
查看 FDA 召回 →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…
查看 FDA 召回 →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…
查看 FDA 召回 →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.
查看 FDA 召回 →GRANUFLO Dry Acid Concentrate: Product Numbers: 0FD2251-3B; 0FD3251-3B; Dry Acid Concentrate for B…
Complaints of blue-green discoloration in product
查看 FDA 召回 →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…
查看 FDA 召回 →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…
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