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 Healthmark Instrument Channel Brushes. SINUS PACK DYNJ48258D and…
Kits contain Healthmark Instrument Channel Brushes, which were recalled by the manufacturer due to the potential for a sharp edge/burr on the end of t…
FDAリコールを見る →Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressur…
A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.
FDAリコールを見る →Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) PBCGLVBLI…
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 →Achieva 3.0T; Model Numbers (REF): 1. 781177, 2. 781277, 3. 781278, 4. 781344, 5. 781345;
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…
Retrospective report of issues remedied in 2019 with firmware and software patches: 1. Defects in optical bench (OPB) firmware V2.19, which affected t…
FDAリコールを見る →INCA (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP, Replacement Set. Stay-Flex tubing component. …
Potential to exhibit a loose connection between the flexible tubing and the nasal cannula, during assembly or while in use, which may result in loss o…
FDAリコールを見る →Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, GYN …
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 →5008X HD/HDF with Twister Blood Tubing Set Part Number 03-5350-8
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 →Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, ROBO…
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 →Medline Convenience Kits: 1) DYKM1000B, Catalog Number: DYKM1000B; 2) DYKM2187A, Catalog Number: …
The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, all…
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