Events

Recall of DatexOhmeda Cardiocap

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

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
    25501
  • Event Risk Class
    Class 2
  • Event Number
    Z-0611-03
  • Event Initiated Date
    2002-09-16
  • Event Date Posted
    2003-03-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-07-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25936
  • 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
    Oximeter, Ear - Product Code DPZ
  • Reason
    Falsely high blood oxygen saturation readings in some circumstances which could result in no alarm in a critical life-threatening situation.
  • Action
    Medical Device Advisory Notice' letters dated September 16, 2002 were sent to the consignees, gave recommendations about alternative monitoring for certain patients, and stated that there would be a field correction to reduce the possibility of the problem.

Device

DatexOhmeda Cardiocap
  • Model / Serial
    All units with N-XOSAT SpO2 measurement option distributed prior to the recall. September 16, 2002
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide in the United States and worldwide.
  • Product Description
    Datex-Ohmeda Cardiocap/5 Anesthesia Monitor with N-XOSAT SpO2 measurement option
  • Manufacturer
    Datex-Ohmeda

Manufacturer

Datex-Ohmeda
  • Manufacturer Address
    Datex-Ohmeda, 3030 Ohmeda Dr. Box 7550, Madison WI 53707
  • Source
    USFDA