Events

Retiro De Equipo (Recall) de Device Recall Vision Sciences Battery

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 Vision-Sciences, 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
    60806
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0929-2012
  • Fecha de inicio del evento
    2011-12-27
  • Fecha de publicación del evento
    2012-01-29
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2018-07-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106690
  • 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
    Nasopharyngoscope (flexible or rigid) - Product Code EOB
  • Causa
    Vision-sciences is recalling the vision-sciences battery charger due to reports relating to the potential for over-heating and possible burning of the lithium-ion batteries being charged.
  • Acción
    Vision Sciences sent an "URGENT: PRODUCT RECALL NOTIFICATION" letter dated December 27, 2011 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to remove the affected product from inventory. A Tracking/Verification Form was provided for customers to complete and return to the firm. Contact the firm at 800-874-9975 for questions regarding this recall.

Device

Device Recall Vision Sciences Battery
  • Modelo / Serial
    All units are affected. Products which include this item are   VISION SCIENCES CAT. No. ITEM Description;  07-3051 Battery Charger, Lithium-Ion; 07-3051X Battery Charger, Lithium-Ion*;  07-3053 BLS Kit;  07-3053X BLS Kit*;  07-3052 Rechargeable Batteries, Lithium-Ion;  07-3052X Rechargeable Batteries, Lithium-Ion*;  02-2602 ENT-3000 Scope (Standard Set);  02-2602-IN ENT-3000 Scope (Standard Set)*;  02-2602X ENT-3000 Scope (Standard Set)*;  02-4201 ENT-4000 Portable Set;  02-4201X ENT-4000 Portable Set*;   * These products were distributed by Medtronic Xomed/ENT.
  • Clasificación del producto
    Ear, Nose, and Throat Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution
  • Descripción del producto
    Product is a lithium ion battery sold as both a stand-alone accessory, and as part of endoscopy system sets. Stand alone labeling: Vision Sciences Rechargeable Lithium Ion Batteries, Replacement (2) [REF] 07-3052; [MFG Symbol] Vision-Sciences, Inc., 40 Ramland Road South, Orangeburg, NY 10962 USA. || Accessory to endoscopy kits used to charge/recharge lithium ion batteries.
  • Manufacturer
    Vision-Sciences, Inc.

Manufacturer

Vision-Sciences, Inc.
  • Dirección del fabricante
    Vision-Sciences, Inc., 40 Ramland Rd S, Orangeburg NY 10962-2623
  • Source
    USFDA