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。
Oncology sets with drip chambers
Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyviny…
FDAリコールを見る →Medline Convenience Kit: OPEN HEART A PACK, Product Number DYNJ43008N
The kits contain a Retrograde Coronary Sinus Perfusion (RCSP) cannulae that has the potential for a sterile barrier breach. Sterility of the product c…
FDAリコールを見る →Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT,MAXIL…
The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing proc…
FDAリコールを見る →LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS US, Model …
There is potential for a delay in AF Burden Alert notification affecting the server software which supports the Insertable Cardiac Monitors (ICMs). De…
FDAリコールを見る →Philips Brilliance CT 64: Brilliance CT 64 Channel Product Code: 728231, Brilliance CT 64 Upgrades P…
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 →VITEK 2 AST-N461 TEST KIT, GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED, Reference Number 424811
The issue is related to card pouch damage associated with a portion of the lot which was produced on a specific card pouching device, in a specific ti…
FDAリコールを見る →Halyard medical convenience kits labeled as: 1) ENT, Model/Item Number (kit) ACEN89-01; 2) ENT,…
The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed¿ Neurological Sponges Non-…
FDAリコールを見る →IV Sets with drip chambers
Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyviny…
FDAリコールを見る →MR 7700 and Upgrade to MR 7700; Model Number (REF): 1. 782120, 2. 782153, 3. 782130 (Upgrade);
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 →Happiest Baby, Inc SNOO Sleep Sack, X-Small Model/Catalog Number: S2101-101 S2101-108-6 S2101-133 …
Extra small (ES) and Extra-large (XL) infant sleep sacks have not been reviewed for safety and effectiveness by the FDA.
FDAリコールを見る →