Events

Recall of Spacelabs

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
    27598
  • Event Risk Class
    Class 2
  • Event Number
    Z-0269-04
  • Event Initiated Date
    2003-10-29
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-09-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=30160
  • 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
    Display, Cathode-Ray Tube, Medical - Product Code DXJ
  • Reason
    Potential for power supply to fail resulting in failure of the audio (alarm tones) to fail.
  • Action
    A letter dated October 31, 2003 was sent on October 29-31, 2003 to all US customers via FED-EX. An ORDER FORM accompanied the letter for consignees to request a replacement power supply or to indicate they did not have the affected power supply.

Device

Spacelabs
  • Model / Serial
    Date code range: 0001xx through 0152xx. All defective power supplies fall within the date code of week 1, 2000 and week 52, 2001. The date code can be found on the underside of the power supply, embossed at the top of the text. It will be in the format of 0108A3, which means ''01'' is the year 2001, ''08'' is week 8 and ''A3'' is the line A3.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The firm distributes to hospitals nationwide. The firm also distributes internationally.
  • Product Description
    Spacelabs flat panel monitor, Model 91415-A
  • Manufacturer
    Datex-Ohmeda, Inc.

Manufacturer

Datex-Ohmeda, Inc.
  • Manufacturer Address
    Datex-Ohmeda, Inc., 5150 220th AVE SE, Issaquah WA 98029
  • Source
    USFDA