Events

Recall of Device Recall Agfa HeartLab Cardiovascular DICOMstore

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
    46381
  • Event Risk Class
    Class 2
  • Event Number
    Z-1241-2008
  • Event Initiated Date
    2007-06-21
  • Event Date Posted
    2008-06-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-08-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=67336
  • 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
    Echocardiogram (ECG) System - Product Code LLZ
  • Reason
    Misidentification: the electrocardiogram (ecg) data of one patient is misidentified as the data of another patient.
  • Action
    On 6/21-26/2007, AGFA Healthcare notified, via telephone, the affected consignees of the situation. On 7/2/2007, affected consignees were sent, via registered mail, an "Urgent Medical Device Correction" letter instructing them to: a) remove the affected software DICOMstore 2.04.40.00 and replace it with the prior software version, DICOMstore 2.04.34.02; and b) review patient ECG reports to determine if any patients were actually affected and to notify the firm. AGFA Healthcare also provided a customer service contact number (877) 777-2432.

Device

Device Recall Agfa HeartLab Cardiovascular DICOMstore
  • Model / Serial
    DICOMstore, L9M8E, Software version: 2.04.40.00
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distributution - USA, including states of AZ, CA, DC, FL, IL, IN, KY, MA, ME, MN, MS, OH, OK, OR, NH, PA, SC, TN, TX, WI, and country of Canada.
  • Product Description
    Agfa HeartLab Cardiovascular DICOMstore Version 2.04.40.00 software, Heartlab, Inc., Westerly, Rhode Island 02891. The software is used in the Agfa HeartLab Cardiovascular System.
  • Manufacturer
    AGFA Corp.

Manufacturer

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