Events

Rappel de Device Recall VISU 200

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 Carl Zeiss Meditec 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
    52716
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0904-2011
  • Date de mise en oeuvre de l'événement
    2009-05-18
  • Date de publication de l'événement
    2011-01-14
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-02-09
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=83806
  • 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
    Microscope, surgical - Product Code EPT
  • Cause
    Potential retina damage-- an error in the user manual may result in misapplied filter and injury during treatment.
  • Action
    Carl Zeiss Meditec Inc sent a SAFETY ALERT letter dated May 18, 2009, via Federal Express to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were reminded to use the correct retinal protection filter (GG475) when using the OPMI VISU 200 system during ophthalmic surgery. Verify the position of the retinal protection filter and inform their staff of the customizable feature. Verify that the correct filter was in place. Customers were asked to complete the acknowledgement form indicating receipt of the alert. Sign and return the form to: Carl Zeiss Meditec in Dublin, California via the enclosed self-addressed, pre-paid Federal Express envelope. For any questions customers should call (925) 557-4422.

Device

Device Recall VISU 200
  • Modèle / numéro de série
    User manuals with numbers G-30-1246-e, G-30-1284-e, G-30-1284-en, and G-30-1236-en, affecting all stands.
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution including USA (nationwide) and the UK
  • Description du dispositif
    VISU 200 on S8 Floor Stand, Manufactured by Carl Zeiss Surgical GmbH, Germany || Medical device: Surgical microscope used during ophthalmic surgeries, which allows real time visualization of the surgical area. || Product Quantity Distributed (Int) 2540 units
  • Manufacturer
    Carl Zeiss Meditec Inc

Manufacturer

Carl Zeiss Meditec Inc
  • Adresse du fabricant
    Carl Zeiss Meditec Inc, 5160 Hacienda Dr, Dublin CA 94568
  • Société-mère du fabricant (2017)
    Carl-Zeiss-Stiftung
  • Source
    USFDA