Events

Recall of Device Recall Exradin

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Standard 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
    26445
  • Event Risk Class
    Class 3
  • Event Number
    Z-0952-03
  • Event Initiated Date
    2003-05-28
  • Event Date Posted
    2003-06-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-07-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=27700
  • 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
    Accelerator, Linear, Medical - Product Code IYE
  • Reason
    Ionization chambers, used for checking x-ray equipment, were experiencing some drift from the tested calibration factors.
  • Action
    The consignees were telephoned on May 28, 2003 and informed of the problem and recall, and sent a recall letter, dated May 28, 2003, requesting the return of the product.

Device

Device Recall Exradin
  • Model / Serial
    Serial numbers XA030414, XA030413, XA030412, XA030411, XA030281, XA030225, XA030224, XA023341, XA023251, XA022101, XA021649, XA021645, XA021642, XA021641, XA020741, XA020176, XA020171, XA020143, XA013118, XA012743, XA012741, XA011444, XA392, 390, and  345
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The product was shipped to 24 hospitals located nationwide in the United States.
  • Product Description
    Exradin A12 Ionization Chamber
  • Manufacturer
    Standard Imaging Inc.

Manufacturer

Standard Imaging Inc.
  • Manufacturer Address
    Standard Imaging Inc., 7601 Murphy Rd, Middleton WI 53562
  • Source
    USFDA