Events

Rappel de Device Recall Widefield OCT software

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 Heidelberg Engineering.

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
    79453
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1535-2018
  • Date de mise en oeuvre de l'événement
    2017-12-08
  • 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=162348
  • 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
    Tomography, optical coherence - Product Code OBO
  • Cause
    Fda notified heidelberg engineering that a 510(k) clearance is needed for the spectralis widefield oct feature, and, on november 27, 2017, heidelberg engineering submitted a new 510(k) for this feature. fda has asked heidelberg engineering to instruct customers not to use the widefield oct software feature on the spectralis device until 510(k) clearance has been obtained for this software feature.
  • Action
    On December 14, 2017 an URGENT Medical device software field correction letter was issued to customers via email or ground mail to notify all customers of the recall action. The letter states the following: FDA has asked us to instruct you not to use the Widefield OCT feature on your SPECTRALIS device until a decision is made on this pending 510(k) submission. Heidelberg Engineering will notify you immediately upon completion of the FDAs review. In the meantime, you may continue to use your Widefield Objective for cSLO fundus imaging (including Fluorescein Angiography, ICG Angiography, MultiColor, Infrared and Red-Free Fundus Imaging). Questions or concerns can be directed to (508) 530-5904

Device

Device Recall Widefield OCT software
  • Modèle / numéro de série
    The Widefield OCT software feature was made available on the SPECTRALIS Software US versions 6.3 to 6.8a It is only usable with the Widefield Objective Module accessory and a dedicated license.
  • Classification du dispositif
    Ophthalmic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationally
  • Description du dispositif
    Widefield OCT software feature for the Spectralis HRA+OCT and variants
  • Manufacturer
    Heidelberg Engineering

Manufacturer

Heidelberg Engineering
  • Adresse du fabricant
    Heidelberg Engineering, 10 Forge Pkwy, Franklin MA 02038-3137
  • Société-mère du fabricant (2017)
    Heidelberg Engineering Inc.
  • Source
    USFDA