Events

Retiro De Equipo (Recall) de Sierra Scientific Motility Visualization System (MVS)

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Sierra Scientific Instruments Inc.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    60175
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0135-2012
  • Fecha de inicio del evento
    2011-10-12
  • Fecha de publicación del evento
    2011-10-28
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-08-30
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104678
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    System, gastrointestinal motility (electrical) - Product Code FFX
  • Causa
    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.
  • Acción
    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)
  • Modelo / Serial
    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,
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) and the countries of: Austria, Belgium, Canada, Chile, China, Columbia, Ecuador, France, Germany, Israel, Mexico, Poland, Portugal, Sweden, and Switzerland.
  • Descripción del producto
    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
  • Dirección del fabricante
    Sierra Scientific Instruments Inc, 5757 W Century Blvd Ste 660, Los Angeles CA 90045-6456
  • Source
    USFDA