Events

Recall of Device Recall Widefield OCT software

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Heidelberg Engineering.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    79453
  • Event Risk Class
    Class 2
  • Event Number
    Z-1535-2018
  • Event Initiated Date
    2017-12-08
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162348
  • Notes / Alerts
    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.
  • Extra notes in the data
    Tomography, optical coherence - Product Code OBO
  • Reason
    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
  • Model / Serial
    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.
  • Product Classification
    Ophthalmic Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationally
  • Product Description
    Widefield OCT software feature for the Spectralis HRA+OCT and variants
  • Manufacturer
    Heidelberg Engineering

Manufacturer

Heidelberg Engineering
  • Manufacturer Address
    Heidelberg Engineering, 10 Forge Pkwy, Franklin MA 02038-3137
  • Manufacturer Parent Company (2017)
    Heidelberg Engineering Inc.
  • Source
    USFDA