Events

Rappel de Vision Elect HDTV Surgical Viewing Monitor

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 Stryker Endoscopy.

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
    49549
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-0196-2009
  • Date de mise en oeuvre de l'événement
    2008-09-22
  • Date de publication de l'événement
    2008-10-24
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2010-12-21
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73786
  • 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
    General & Plastic Surgery Laparoscope - Product Code GCJ
  • Cause
    Knob parts stick together, resulting in poor functionality of the knob.
  • Action
    Urgent: Device Correction letters dated 9/22/2008 were sent to Sales representatives and all accounts. Sales reps were also notified via email. Each Sales Rep was provided rework instructions, a list of affected accounts and serial numbers, and new knobs to install on affected units. Customers were asked to inspect their inventory for the part number, they were informed that their sales rep would be responsible for replacing the rotary knobs on all affected units, and that they should contact their sales rep to schedule the knob replacement.

Device

Vision Elect HDTV Surgical Viewing Monitor
  • Modèle / numéro de série
    PER Number(s): 98131, 99085,101141,105591,101235,101212, 109617, 110104, 110852,110974,111006,111048,111081,111105, 111181, 111199, 111202, 111303, 111492, 111562, 111595, 111868, 111912, and 111935
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution --- USA including states of Alabama, Arkansas, Arizona, California, Colorado, Connecticut, DC, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia, and Wyoming, and countries of Australia, Canada, China, England, France, Germany, Greece, Iberia, India, Israel, Japan, Korea, Mexico, Netherlands, Poland, Portugal, Scandinavia, Singapore, South Africa, Switzerland, and Taiwan.
  • Description du dispositif
    26" Vision Elect HDTV Surgical Viewing Monitor, model number 0240030960, Manufactured by Stryker Endoscopy San Jose || Intended to be used as a visualization device for events occurring in the sterile field for endoscopic surgical procedures.
  • Manufacturer
    Stryker Endoscopy

Manufacturer

Stryker Endoscopy
  • Adresse du fabricant
    Stryker Endoscopy, 5900 Optical Ct, San Jose CA 95138
  • Source
    USFDA