Events

Recall of DatexOhmeda Cardiocap/5

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
    27599
  • Event Risk Class
    Class 3
  • Event Number
    Z-0143-04
  • Event Initiated Date
    2003-10-17
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-11-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=30161
  • 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
    Datex-ohmeda cardiocap/5 patient monitors have bracket pins which do not adequately secure them to their optional mounting stand so the monitors may fall.
  • Action
    Recall letters dated October 15, 2003 were sent to the consignees on 10/17/03. The letters request that the consignees order service kits to correct the units and use the kits to make the corrections of the devices.

Device

DatexOhmeda Cardiocap/5
  • Model / Serial
    The monitors in the serial number range FBWF00725 through FBWF03055 and FBWG00001 through FBWG02015 could be affected by the problem if they are mounted on the optional mounting stands for the product. The consignees notified of the field correction had purchased both the monitors and the stands.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The monitors were shipped to consignees located nationwide in the United States and to foreign consignees located worldwide.
  • Product Description
    Datex-Ohmeda Cardiocap/5 Patient Monitors
  • Manufacturer
    Datex-Ohmeda Inc

Manufacturer

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