Events

Recall of Device Recall IMPAX RIS QDOC 5.8 and higher

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by AGFA 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
    67275
  • Event Risk Class
    Class 2
  • Event Number
    Z-0919-2014
  • Event Initiated Date
    2014-01-08
  • Event Date Posted
    2014-02-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-02-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125138
  • 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
    System, image processing, radiological - Product Code LLZ
  • Reason
    Patient name displayed (printed) on the patient report was the wrong patient name.
  • Action
    On January 8, 2014, an "URGENT FIELD SAFETY NOTICE" (UFSN) letter was emailed to consignees. The letter described the safety alert and mitigation, including directions to consignees as to how the disable Microsoft Word Background Printing. Acknowledgment via FAX-Back or email, that the information was received and understood was requested from the consignees.

Device

Device Recall IMPAX RIS QDOC 5.8 and higher
  • Model / Serial
    Software IMPAX RIS 58 and higher
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    CA, FL, GA, ME, OH, OR, SC, SD, TX and Canada
  • Product Description
    IMPAX RIS QDOC 5.8
  • Manufacturer
    AGFA Corp.

Manufacturer

AGFA Corp.
  • Manufacturer Address
    AGFA Corp., 10 S Academy St, Greenville SC 29601-2632
  • Source
    USFDA