Events

Recall of Device Recall Boston Scientific SpyGlass Camera

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

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
    37403
  • Event Risk Class
    Class 2
  • Event Number
    Z-0699-2007
  • Event Initiated Date
    2007-02-07
  • Event Date Posted
    2007-03-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-11-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50493
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • Extra notes in the data
    Video Camera System - Product Code KOG
  • Reason
    A teal "bloom"/ glare on the subject image during high light conditions.
  • Action
    Boston Scientific notified accounts by letter dated 2/1/07 requesting return of product.

Device

Device Recall Boston Scientific SpyGlass Camera
  • Model / Serial
    Lot Numbers: 061005, 061006, 061007, 061009, 061010, 0161011, 061012, 610130, 61014, 061015, 061016, 061017
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution --- including states of CA, CO, FL, OH, MA, MN, MO NY, PA, SC,TX, and WA .
  • Product Description
    Boston Scientific SpyGlass Camera || Ref Number: 4610 UPN M00546100
  • Manufacturer
    Boston Scientific Corporation

Manufacturer

Boston Scientific Corporation
  • Manufacturer Address
    Boston Scientific Corporation, 1 Boston Scientific Pl, Natick MA 01760-1536
  • Source
    USFDA