Events

Rappel de Sierra Scientific Motility Visualization System (MVS)

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Sierra Scientific Instruments Inc.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    60175
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0135-2012
  • Date de mise en oeuvre de l'événement
    2011-10-12
  • Date de publication de l'événement
    2011-10-28
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-08-30
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104678
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    System, gastrointestinal motility (electrical) - Product Code FFX
  • Cause
    The recall was initiated after given imaging received a test report during a canadian licensing process where the ar manoshield exhibited pinholes and did not pass the test, the field safety corrective action (fsca) committee was convened. as a result of the data discussed during this meeting, a decision was made to voluntarily recall this product, and cease its further commercialization or distr.
  • Action
    Given Imaging sent an "Urgent Product Recall 1st Notice" letter with an attached Device Recall Confirmation Form (via Fed Ex with signature for tracking purposes) to all customers who purchased the AR ManoShield, part numbers MSS-3599. The letter provides the customers with an explanation of the problem identified and actions to be taken. Customers were instructed to locate the affected product and removed from use immediately. The letter stated that if the affected product have been further distributed, forward this letter immediately to all customers who received the affected product. Customers were asked to complete and return the enclosed confirmation form as per the instructions. Customers with any questions were instructed to contact Karla Guerrero at (310) 641-8492 ext. 2138 or email at karla.guerrero@givenimaging.com.

Device

Sierra Scientific Motility Visualization System (MVS)
  • Modèle / numéro de série
    F1112702UA, F1113101UA, F1113103UA, F1113104UA, F1113401UA, F1114201UA, F1114617UA, F1114618UA, F1114619UA, F1114620UA, F1114621UA, F1114623UA, F1114624UA, F1114625UA, F1114626UA, F1114627UA, F1114628UA, F1114629UA, F1115402UA, F1116306UA, F1117207UA, F1119201UA, F1119401UA, F1121304UA, F1123201UA, F1123405UA, F1123703UA, F1124202UA, F1124301UA, F1125105UA, F1125201UA, F1127303UA, F1128101UA, F1129701UA, F1130202UA, F1130304UA, F1128301UA, F1127103UA, F1127205UA,
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of: Austria, Belgium, Canada, Chile, China, Columbia, Ecuador, France, Germany, Israel, Mexico, Poland, Portugal, Sweden, and Switzerland.
  • Description du dispositif
    AR ManoShield, MSS-3599, 10 pack. || FGS: MSS-3599, || Individual package label: LBL-110275-03, || Box label: LBL-110282-03, || Package Inserts: DOC-3682, || User Manual: DOC-1332-12. || Product Usage: The MVS disposable sheath (a.k.a. ManoShield) for the high-resolution MVS catheter is designed to provide a biocompatible barrier between the catheter and patient.
  • Manufacturer
    Sierra Scientific Instruments Inc

Manufacturer

Sierra Scientific Instruments Inc
  • Adresse du fabricant
    Sierra Scientific Instruments Inc, 5757 W Century Blvd Ste 660, Los Angeles CA 90045-6456
  • Source
    USFDA