Events

Recall of Device Recall Advantage Workstation

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by GE Healthcare.

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
    48738
  • Event Risk Class
    Class 2
  • Event Number
    Z-2312-2008
  • Event Initiated Date
    2008-05-01
  • Event Date Posted
    2008-09-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-12-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72026
  • 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
    Ge healthcare has recently became aware of a possible mismatch between the label of the tracked vessel and the underlying image associated with the cardio- vascular applications of the advantage workstation that may impact patient safety.
  • Action
    Consignees were sent a GE "Urgent Field Safety Notice" letter dated March 13, 2008 addressed to Hospital Administrators; Managers of Radiology/Cardiology; Radiologists/Cardiologists on May 2008. The letter described the safety issue, affected product, product correction, safety instructions and contact information. A GE Field Engineer to visit site to implement the correction (FMI No. 25409). Contact information: 800-437-1171 (USA); 0120-055-919 (Japan); 0800-15-25-25 (France); for all other countries contact your local GE Healthcare sales or field representative.

Device

Device Recall Advantage Workstation
  • Model / Serial
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    AK AL AR AZ CA CO CT DC DE FL GA HI IA ID IL IN KS KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NY OH OK OR PA RI SC SD TN TX UT VA VT WA WI WV WY Algeria Argentina Australia Austria Belgium Bosnia Brazil Bulgaria Byelorussian SSR Canada Chile China Columbia Croatia Cyprus Czech Denmark Dominican Republic Ecuador Egypt Finland France French Polynesia Georgia Germany Greece Guadeloupe Guatemala Guyana Honduras Hungary India Indonesia Iran Ireland Israel Italy Jamaica Japan Korea Kuwait Lebanon Libyan Arab Jamahiriya Lithuania Luxembourg Macedonia Malaysia Mexico Morocco Netherlands New Zealand Norway Oman Pakistan Panama Paraguay Peru Philippines Poland Portugal Puerto Rico Puerto Rico Romania Russia Saudi Arabia Singapore South Africa Spain Sweden Switzerland Taiwan Thailand Trinidad Tunisia Turkey Ukraine United Aran Emirates United Kingdom Uruguay Venezuela Vietnam Yugoslavia
  • Product Description
    Advantage Workstation version 4.2P, 4.3 and 4.4 with Volume Viewer 2 and Volume Viewer 3. Model Numbers 5183652 & 5142878.
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare
  • Manufacturer Address
    GE Healthcare, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Manufacturer Parent Company (2017)
    General Electric Company
  • Source
    USFDA