Events

Rappel de Device Recall Optical Coherence Tomography System

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 Optovue, 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
    77776
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0010-2018
  • Date de mise en oeuvre de l'événement
    2017-07-27
  • 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=157860
  • 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
    Ophthalmoscope, ac-powered - Product Code HLI
  • Cause
    Fda determined that a 510(k) is needed for the vault mapping software (also known as lens fitting).
  • Action
    Optovue sent an Urgent Medical Device Software Field Correction letter dated July 27, 2017, via FedEx mail. Customers were Instructed to discontinue use of the Vault Mapping software, to complete and return the recall response form, and to provide remote access to units to an Optovue representative so that new software can be downloaded remotely. Questions can be addressed by calling Optovue at 1-866-941-9240.

Device

Device Recall Optical Coherence Tomography System
  • Modèle / numéro de série
    Cat No. 700-49428-001 (GTIN - N/A), 700-49428-002 (GTIN 00858848006315), 700-49428-003 (GTIN 00858848006018).
  • Classification du dispositif
    Ophthalmic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Nationwide Distribution in the states of - AL, AR, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, WA, WI, & WV.
  • Description du dispositif
    iVue 500 with iScan, D216606. || Product non-contact, high resolution tomographic imaging device. It is intended for in vivo imaging, axial cross-sectional and three-dimensional imaging and measurement of anterior and posterior ocular structures, including retina, retinal nerve fiber layer, ganglion cell complex (GCC), optic disc, cornea, and anterior chamber of the eye. The iVue 500 with normative database is a quantitative tool for the comparison of retina, retinal nerve fiber layer, ganglion cell complex, and optic disc measurements to a database of known normal subjects. The iVue 500 with normative database is indicated for use as a device to aid in the diagnosis, || documentation, and management of ocular health and diseases in the adult population.
  • Manufacturer
    Optovue, Inc.

Manufacturer

Optovue, Inc.
  • Adresse du fabricant
    Optovue, Inc., 2800 Bayview Dr, Fremont CA 94538-6518
  • Société-mère du fabricant (2017)
    Optovue Inc.
  • Source
    USFDA