FDA医療機器リコール
FDAによる最新の医療機器リコール、修正、撤去情報。医療機器の安全問題を確認できます。
Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ADULT BLOOD CULTURE KIT…
Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may have an open…
FDAリコールを見る →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 …
FDAリコールを見る →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…
FDAリコールを見る →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.
FDAリコールを見る →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…
FDAリコールを見る →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…
FDAリコールを見る →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.
FDAリコールを見る →GRANUFLO Dry Acid Concentrate: Product Numbers: 0FD2251-3B; 0FD3251-3B; Dry Acid Concentrate for B…
Complaints of blue-green discoloration in product
FDAリコールを見る →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…
FDAリコールを見る →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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