Events

Recall of Device Recall GE Healthcare CARESCAPE Patient Data Module

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
    67161
  • Event Risk Class
    Class 2
  • Event Number
    Z-0648-2014
  • Event Initiated Date
    2013-12-16
  • Event Date Posted
    2014-01-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-04-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124801
  • 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 healthcare has recently become aware of a potential safety issue which affects all patient date modules produced from april 2007 through june 2010, encompassing fiscal week 13, 2007 through 26, 2010 due to fluid ingress into the top cover assembly which can result in heat buildup.
  • Action
    Consignees were sent on 12/16/2013 a GE Healthcare "Urgent Medical Device Correction" letter dated December 5, 2013. The letter was addressed to Healthcare Administrator / Risk Manger, Chief of Nursing and Director of Biomedical Engineering. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information (Contact Technical Support at 1-800-558-7044 or your local Service Representative).

Device

Device Recall GE Healthcare CARESCAPE Patient Data Module
  • Model / Serial
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) including states of: AL, AZ, AR, CA, CO, CT, DC, FL, GA, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, O, NE, NV,NH, NJ, NM, NY, NC, OH, OK, OR,PA PR, RI,SC, TN, TX, UT, VT, VA, WA, WI, and WY. Internationally to: ARGENTINA, AUSTRALIA, AUSTRIA, BANGLADESH, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, CZECH REPUBLIC, DENMARK, EGYPT, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, GUATEMALA, INDIA, INDONESIA, IRELAND, ISRAEL, ITALY, JAMAICA, JAPAN, JORDAN, REPUBLIC OF KOREA, KUWAIT, LEBANON,LITHUANIA, MALAYSIA, MAURITIUS, MOROCCO, NETHERLANDS, NEW ZEALAND, NORWAY, POLAND, QATAR , SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TRINIDAD AND TOBAGO, TUNISIA, TURKEY, UNITED ARAB EMIRATES, and UNITED KINGDOM.
  • Product Description
    SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthcare CARESCAPE Patient Data Module)
  • 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