Events

Recall of RM, RMAT

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
    57820
  • Event Risk Class
    Class 2
  • Event Number
    Z-1435-2011
  • Event Initiated Date
    2009-04-15
  • Event Date Posted
    2011-02-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-10-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97505
  • 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
    User could modify a measurement's units and that change would not be reflected in echocardiography formulas used within the adult echocardiography rm.
  • Action
    The firm, Agfa Healthcare, sent individual letters dating from April 15, 2009 to August 26, 2009, to the customers. The letters described the product, problem and actions to be taken. Agfa provided the affected customer with a complete list of their impacted patients and the measurements. Agfa also scheduled unit corrections with their customers and received acknowledgement of the letters at the time of scheduling the unit corrections. Service Bulletin DIS026.09E was issued January 2009 to inform users that Agfa will no longer allow customers to request unit changes for measurements that have formulas. Note: Technical Support ran diagnostic scripts for each customer and documented in GSC cases for each consignee/customer. If you have any questions, contact Agfa Healthcare at (949) 830-4959.

Device

RM, RMAT
  • Model / Serial
    Software Versions: RM 2.03, 2.04 & 2.06
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution: USA including states of: IL, MT, NY, OR and SC.
  • Product Description
    IMPAX CV Results Manager/Results Manager Administration Tool || The IMPAX Cardiovascular suite is a cardiovascular information system providing image archiving and image display and modality study-specific structured reporting. The suite is comprised of modular software that runs on industry standard personal computers and servers, utilizing Windows 2000/2003/XP operating systems. Image data storage/display utilizes DICO< (Digital Imaging and Communications in Medicine) data primarily from independent medical devices.
  • Manufacturer
    AGFA Corp.

Manufacturer

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