Events

Recall of Device Recall Seno Advantage 2.2

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

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
    61612
  • Event Risk Class
    Class 2
  • Event Number
    Z-0125-2013
  • Event Initiated Date
    2012-05-24
  • Event Date Posted
    2012-10-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-12-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108537
  • 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 become aware of inaccurate scale factor annotation provided by senoadvantage 2.2 workstations that may impact patient safety. this issue may result in a potential miscalculation of size.
  • Action
    Consignees were sent on 5/24/12 a GE Healthcare "Urgent Medical Device Correction" letter dated May 23, 2012. The letter was addressed to Hospital Administrators / Risk Managers, Radiology Department Managers & Radiologists. The letter described the Safety Issue, Safety Instructions, Affected Product Details, and Product Correction. Customers should verify if their workstation is affected. GE Healthcare will correct all affected workstations by providing a software upgrade and Operator Manual update. A GE Healthcare service representative will contact you to arrange this correction. This activity will be performed at no cost to you. If you have any questions or concerns regarding this notification, please call one of the following phone numbers: United States: 800 437 1171 Japan: 0120 - 055 - 919 For other countries, please contact your local GE Healthcare Service Representative.

Device

Device Recall Seno Advantage 2.2
  • Model / Serial
    000000010005GS 000000010004GS 000000010009GS 000000010007GS 000000010006GS 000000010010GS 000000010001GS 000000010002GS 000000010008GS 000000010003GS 00000L3A4391A7 00000L3A8D5CF0
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA (nationwide) including states of: CA, CT, NY, TX, and MS and countries of TAIWAN, ITALY, CANADA, and BAHRAIN
  • Product Description
    GE Healthcare, Seno Advantage 2.2 workstations with software version 22_01 and 22_02 || A medical image review station that allows easy selection, processing, filming and media interchange of multi-modality images from a variety of diagnosis imaging systems.
  • Manufacturer
    GE Healthcare, LLC

Manufacturer

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