Events

Recall of Device Recall GE DatexOhmeda Engstrom Carestation

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Datex - Ohmeda, Inc.

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
    44927
  • Event Risk Class
    Class 2
  • Event Number
    Z-1526-2008
  • Event Initiated Date
    2007-07-02
  • Event Date Posted
    2008-08-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-07-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=64537
  • 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
    Ventilator - Product Code CBK
  • Reason
    Neonatal flow sensors supplied for use with the neonatal enhancement for the engstr¿m carestation may result in the sensors providing invalid values and alarm messages when exposed to high flow rates.
  • Action
    Consignees were sent a Medical Device Correction Notification letter on July 2, 2007. The firm's short term recommendation is that Neonatal Flow Sensors may continue to be used with added viligance around potential patient circuit disconnections and the associated alarms. Ther firm recommends that the MV exp high and Circuit leak alarms be set appropriately for each patient in order to detect a patient disconnect. The long term recommendation was to order the replacement part when available and dispose of the old part when the replacement is received.

Device

Device Recall GE DatexOhmeda Engstrom Carestation
  • Model / Serial
    All serial numbers
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution --- USA including state of TX and countries of Austria, Bangladesh, Belgium, Costa Rica, Denmark, Finland, France, Germany, India, Italy, Mexico, Saudi Arabia, South Africa, Sweden, Switzerland, United Kingdom, United Arab Emirates.
  • Product Description
    GE Datex-Ohmeda Neonatal Enhancement for the Engstrom Carestation, Model # 1505-3272-00, GE Healthcare P.O. Box 7550, Madison, WI 53707-7550, USA || Intended to provide mechanical ventilation for adults and pediatrics weighing 5kg and above having degrees of pulmonary impairment varying from minor to severe.
  • Manufacturer
    Datex - Ohmeda, Inc

Manufacturer

Datex - Ohmeda, Inc
  • Manufacturer Address
    Datex - Ohmeda, Inc, Po Box 7550, Madison WI 53707
  • Source
    USFDA