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
    67115
  • Event Risk Class
    Class 2
  • Event Number
    Z-0747-2014
  • Event Initiated Date
    2013-11-27
  • Event Date Posted
    2014-01-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-09-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124725
  • 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 due to intermittent failure of the spring loaded mounting latch of pdms produced from april 2007 through december 2012.
  • Action
    The firm, GE Healthcare, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated November 26, 2013 to its consignees/customers. 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. The consignees/customers were instructed to please ensure that all potential users in your facility are made aware of this safety notification and the recommended actions. GE Healthcare will provide a new latch at no charge once it is available. GE will contact you to arrange for installation of the latch. If you have any questions regarding this notification, please 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, NO, NE, NV, NJ, NM, NY, NC, OH, OK,OR, PA, RI, SC, TN, TX, UT,VT, VA, WA, WI, and WY. Internationally to: Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Czech Republic, Denmark, Egypt,England, Estonia, Finland,France, Germany,Greece, Guatemala, Hungary,India, Indonesia, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Korea, Kuwait, Lebanon, Lithuania, Malaysia, Mauritius, Mexico, Morocco, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Poland, Portugal, Qatar, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Republic of China, Thailand, Trinidad and Tobago, Tunisia, Turkey, United Arab Emirates and United Kingdom.
  • Product Description
    GE Healthcare Carescape Patient Data Module || The Patient Data Module (PDM) is intended to provide uninterrupted acquisition of physiologic parameter data on adult, pediatric and neonatal patients during non-transport/bedside and transport patient care episodes.
  • 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