Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen
449 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen
- Datum
- Relevantie
-
St. Jude Medical, FA-Q123-SH-2 Trifecta, Trifecta Valve, Trifecta Valve w. Glide Technology
Op 27 februari 2023 heeft Abbott al laten weten dat de mogelijkheid van Structural Valve Deterioration (Structurele ...
-
MAQUET Cardiovascular, LLC, 2242352-06/20/2023-003-R, ACCESSRAIL Platform and Acrobat Systems
Maquet/Getinge is initiating a voluntary Medical Device Field Safety Notice-Removal for the ACCESSRAIL Platform Standard Blade ...
-
Equimedical BV, 2-2023, Equitamp and Equicel and equispon
In March 2023 the Health and Youth Care Inspectorate (NL) received a compliance and enforcement request (CEF) fom Agentia ...
-
Cook Vandergrift Inc., 2023FA0008, Lead Clippers
Cook Medical Vandergrift heeft vastgesteld dat de V-vormige verzegeling van de draadknipperverpakking volledig verbroken kan ...
-
Gyrus ACMI Inc., QIL FY24-EMEA-05-FY23-OSTA-17, UroPass Ureteral Access Sheath Set
The investigation showed that reported breakages were associated with devices aged more than three years.
-
MEDICREA INTERNATIONAL S.A., FSN-FA1335, GRANVIA-C, IMPIX ALIF, IMPIX ALIF S/A, IMPIX C+. IMPIX DLIF, IMPIX MANTA, IMPIX MANTA+, IMPIX S, IMPIX TLIF, PASS LP
Tijdens een intern onderzoek ontdekte Medtronic de mogelijkheid van een productconformiteitsprobleem in de vorm van een gaatje in ...
-
Smith & Nephew Medical Limited, C-2023-05, Secura No-Sting Skin-Prep.Barrier Film
Productiefout die resulteert in de aanwezigheid van azijnzuur, wat een azijnachtige geur en mogelijke lichte huidirritatie ...
-
TROKAMED GmbH, 2023 VIG 105233 Morcellator, Griffmodul V2.0 5-times-use Morcellator System
In rare cases, the Cutting Module may continue to rotate even though the activation switch on the Grip Module has been released.
-
NVT GmbH, FSN-CAPA 23-10, ALLEGRA Transcatheter Heart Valve
NVT has been informed that there has been a mix-up between an ALLEGRA THV 23 and an ALLEGRA THV 31.lf not identified prior to ...
-
FSN-FSCA 272, Aesculap AG, Laparoscopic access
We detected a non-conformity to the product specification of part number FF399R caused by a manufacturing deviation. The affected ...