Events

Recall of Device Recall Transilluminator Model BFO150

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

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
    45852
  • Event Risk Class
    Class 2
  • Event Number
    Z-0320-2008
  • Event Initiated Date
    2007-11-09
  • Event Date Posted
    2008-01-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-10-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=66264
  • 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
    Transilluminator - Product Code HJM
  • Reason
    Device was marketed without a 510(k).
  • Action
    On 11/09/07, the recalling firm started faxing the Recall Letter and response form to its customers, informing them of the recall of the unapproved device to the user level.

Device

Device Recall Transilluminator Model BFO150
  • Model / Serial
    All Serial Numbers on the market
  • Product Classification
    Ophthalmic Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide: USA, Canada and India
  • Product Description
    Transilluminator, Model BFO-150, a Fiber Optic Light Source (Illuminator), available in 2 voltages: 115v for USA users & 220v for foreign countries. --- Chiu Technical Corporation, 252 Indian Head Road, Kings Park, NY 11754.
  • Manufacturer
    Chiu Technical Corp

Manufacturer

Chiu Technical Corp
  • Manufacturer Address
    Chiu Technical Corp, 252 Indian Head Road, Kings Park NY 11754-4818
  • Manufacturer Parent Company (2017)
    Chiu Technical Corp
  • Source
    USFDA