Events

Rappel de Device Recall Vision Sciences Battery

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 Vision-Sciences, 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
    60806
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0929-2012
  • Date de mise en oeuvre de l'événement
    2011-12-27
  • Date de publication de l'événement
    2012-01-29
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2018-07-06
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106690
  • 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
    Nasopharyngoscope (flexible or rigid) - Product Code EOB
  • Cause
    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.
  • Action
    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
  • Modèle / numéro de série
    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.
  • Classification du dispositif
    Ear, Nose, and Throat Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution
  • Description du dispositif
    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.
  • Adresse du fabricant
    Vision-Sciences, Inc., 40 Ramland Rd S, Orangeburg NY 10962-2623
  • Source
    USFDA