Events

Recall of Device Recall Agfa Heartlab Cardiovascular Results Management Product

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
    46382
  • Event Risk Class
    Class 2
  • Event Number
    Z-1242-2008
  • Event Initiated Date
    2007-07-27
  • Event Date Posted
    2008-06-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-10-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=67337
  • 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
    Electrocardiogram (ECG) System - Product Code LLZ
  • Reason
    Incorrect results: erroneous echocardiographic measurement values due to mathematical formula being mis-configured.
  • Action
    On 7/27/2007 to 8/16/2007, AGFA Healthcare notified, via telephone, consignees of the situation. On 7/27/2007, a formal customer notification letter was sent to affected consignees, providing them with a respective listing of patients that were potentially affected. AGFA informed the consignees that the firm would correct any incorrect patient ECG data. AGFA also informed their consignees that they would provide a configuration update to correct the problem. A notification confirmation form to be return to the firm was also attached to the notification letter, which also provided the firm's customer service number: (877) 777-2432.

Device

Device Recall Agfa Heartlab Cardiovascular Results Management Product
  • Model / Serial
    Results Management Model Number: L58RZ and L9MWQ, Version 2.03 and 2.04
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution -- USA including states of GA, NH, NY and TX
  • Product Description
    Agfa Heartlab Cardiovascular Results Management Product: Versions 2.03 and 2.04. Heartlab, Inc., Westerly, Rhode Island 02891
  • Manufacturer
    AGFA Corp.

Manufacturer

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