Events

Rappel de Device Recall Integra 3

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 RESEARCH INSTRUMENTS LTD - SITE B.

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
    73581
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1584-2016
  • Date de mise en oeuvre de l'événement
    2016-03-11
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144524
  • 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
    Micromanipulators and microinjectors, assisted reproduction - Product Code MQJ
  • Cause
    The units have been fitted with a potentially faulty power supply cable.
  • Action
    Research Instruments sent a recall notification dated 03/11/2016, via UPS with confirmed delivery receipt, to all affected customers. The letter identified the affected product, problem and the action needed to be taken by the customer. The letter asked customers to contact Research Instruments First Line Support if they had any questions.

Device

Device Recall Integra 3
  • Modèle / numéro de série
    Serial numbers: 2-381
  • Classification du dispositif
    Obstetrical and Gynecological Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US Nationwide in the states of: MA, NY and countries of : Algeria, Australia, Austria, Bahrain, Belgium, British Virgin Islands, Bulgaria, Canada, Denmark, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Hong Kong, India, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Korea, Kuwait, Libya, Lithuania, Macedonia, Malaysia, Malta, Mexico, Nigeria, Norway, Pakistan, Peru, Poland, Romania, Serbia, Singapore, Slovakia, South Africa, Spain, Sri Lanka, Sweden, Taiwan, Thailand, Tunisia, Turkey, UAE, Ukraine, United Kingdom, and Vietnam,
  • Description du dispositif
    Integra 3; Model Numbers: 6-54-100, 6-54-110, 6-54-150, 6-54-160 || Product Usage: || The Rl TDU500 Micromanipulator for Assisted Reproduction is used to accurately position microtools under a microscope for the techniques of Assisted Reproduction. The Rl Integra is a configuration comprising two TDU500 micromanipulators, two air syringes and temperature control system within a single housing.
  • Manufacturer
    RESEARCH INSTRUMENTS LTD - SITE B

Manufacturer

RESEARCH INSTRUMENTS LTD - SITE B
  • Adresse du fabricant
    RESEARCH INSTRUMENTS LTD - SITE B, Bickland Ind. Park, Falmouth United Kingdom
  • Source
    USFDA