Events

Recall of Device Recall IMPAX CV Echo Measurement Import via Optical Character Recognition (OCR)

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
    60165
  • Event Risk Class
    Class 2
  • Event Number
    Z-0212-2012
  • Event Initiated Date
    2011-06-06
  • Event Date Posted
    2011-11-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-05-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104633
  • 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
    Incorrect entries in mapping files could lead to inaccurate measurement display in adult and pediatric echo reports when using the impax cv echo measurement import via optical character recognition (ocr).
  • Action
    The firm, AGFA HealthCare" sent an 'URGENT FIELD SAFETY NOTICE" dated May 27, 2011 via FED-EX by June 6, 2011 to all customers using the affected product. The letter describes the product, problem and actions to be taken. The customers were instructed to distribute this information within their facility to all those who need to be aware and to complete and return the attached FEEDBACK FORM via fax to 864-421-1668 or email to debbie.norris@agfa.com. AGFA will provide software corrections to all affected sites and will contact the customers to schedule the analysis and provide any corrections if required. If you have any questions about this matter, please contact your local Agfa HealthCare Service at 877-777-2432.

Device

Device Recall IMPAX CV Echo Measurement Import via Optical Character Recognition (OCR)
  • Model / Serial
    Software Versions - All DICOMStore Version 2.04.44 and earlier
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: AK, AZ, CA, CO, DC, FL, GA, HI, IA, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, WA, WI, and WV; and country of: Canada.
  • Product Description
    IMPAX CV Echo Measurement Import via Optical Character Recognition (OCR) || The IMPAX Cardiovascular suite is a cardiovascular Information system providing image archiving and image display and modality study-specific structured reporting.
  • Manufacturer
    AGFA Corp.

Manufacturer

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