Events

Recall of Device Recall GE Healthcarr Dash Port 2 Docking Station

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
    63662
  • Event Risk Class
    Class 2
  • Event Number
    Z-0814-2013
  • Event Initiated Date
    2012-06-13
  • Event Date Posted
    2013-02-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-08-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114428
  • 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
    Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
  • Reason
    Ge has become aware of multiple issues affecting the dash 3000/4000/5000 and dashport 2 monitor. this report of correction encompasses the dashport 2 device, in which the dashport 2 stops communicating with the dash, resulting in loss of monitoring at the cic. the dashport 2 status leds in the back of the unit indicate unity network and dashport 2 to dash communication has stopped.
  • Action
    GE Healthcare sent an Important Product Information Letter dated June 13, 2012 via FedEx to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter indicated that the motherboard would be replaced, on request, should the customer continue to experience the issue. A second letter dated August 30th 2012 was issued informing consignees that the correction that was initially proposed did not fully correct the issues. Therefore, the motherboard replacement field action had been suspended. It further explained that the correction will be provided at no charge when it is available. For questions contact Technical Support at 1-800-558-7044.

Device

Device Recall GE Healthcarr Dash Port 2 Docking Station
  • Model / Serial
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution and US (nationwide) including DC and the countries of ALGERIA, ARAB EMIRATES, AUSTRALIA, AUSTRIA, BANGLADESH, BELGIUM, BRAZIL, CANADA, CHINA, CYPRUS, CZECH REPUBLIC, DENMARK, EGYPT, FRANCE, GERMANY, INDIA, ISRAEL, ITA LY, JAPAN, JORDAN, KUWAIT, MOROCCO, NETHERLANDS, NEW ZEALAND, NORWAY, POLAND, PORTUGAL, RUSSIA, SAUDI ARABIA, SINGAPORE SLOVENIA, SOUTH KOREA, SPAIN SWEDEN SWITZERLAND, TAIWAN, TURKEY, UNITED KINGDOM.
  • Product Description
    GE Healthcare, Dash Port 2 Docking Station. || Product Usage: is a docking station (quick mount/dismount base) for a Dash patient monitor. The system is to monitor physiologic parameter data on adult, pediatric, and neonatal patients.
  • 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