Events

Recall of Device Recall Given Diagnostic System with PillCam SB Capsule

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

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
    46388
  • Event Risk Class
    Class 2
  • Event Number
    Z-1447-2008
  • Event Initiated Date
    2007-12-13
  • Event Date Posted
    2008-08-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-11-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=67359
  • 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
    Gastrointestinal wireless capsule - Product Code NEZ
  • Reason
    The cards included in the product's education kit (proposing a clinical algorithm for capsule endoscopy in patients with suspected crohn's disease), were printed incorrectly.
  • Action
    Consignees were notified by letter on 12/13/2007. The letter contains a diagram illustrating the error on the incorrect card and a diagram illustrating the corrected card. Consignees were instructed to discard the incorrect card if they still have it and to complete a response form and return it via fax to Given Imaging.

Device

Device Recall Given Diagnostic System with PillCam SB Capsule
  • Model / Serial
    GMB-0253-01-GLR Card-Proposed Diagnostic Algorithm for Suspected Crohn's Disease.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution --- US including Puerto Rico and country of Canada
  • Product Description
    Given¿ Diagnostic System with PillCam¿ SB Capsule - Gastrointestinal capsule imaging system. The device is an ingestible telemetric gastrointestinal capsule imaging system is used for visualization of the small bowel mucosa as an adjunctive tool in the detection of abnormalities of the small bowel. The device captures images of the small bowel with a wireless camera contained in a capsule. This device includes an ingestible capsule (containing a light source, camera, transmitter, and battery), an antenna array, a receiving/recording unit, a data storage device, computer software to process the images, and accessories.
  • Manufacturer
    Given Imaging Inc

Manufacturer

Given Imaging Inc
  • Manufacturer Address
    Given Imaging Inc, 3950 Shackleford Rd, Duluth GA 30096-1858
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA