Events

Recall of Device Recall Ultraview Universal Clinical Workstation (UCW) Model 90385

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Spacelabs Medical Incorporated.

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
    30797
  • Event Risk Class
    Class 2
  • Event Number
    Z-0422-05
  • Event Initiated Date
    2005-01-07
  • Event Date Posted
    2005-01-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-01-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=36615
  • 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
    Weakness of the swivel base for the universal clinical workstation may result in the unit falling from its mounted position endangering users and patients.
  • Action
    All US customers were sent a Medical Device Recall letter on 1/7/2005 describing how to examine monitors for the defect and to discontinue use of any suspect unit s until examintaion by a Field Service Engineer . International customers will be notified via email or letter on 1/14/2005. Follow up contact by Customer Support and Global Support is planned for any customer not responding with a FAX-back form.

Device

Device Recall Ultraview Universal Clinical Workstation (UCW) Model 90385
  • Model / Serial
    Universal Ultraview Clinical Workstation Model 90385 base versions with Revision M or earlier. This recall involves certain units within the serial number range SN: 385-000337 to SN: 385-111440. The firm indicated that not all serial numbers within this range are affected by this recall, but only those units with the specified Revision M or earlier base which have not already been updated.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The firm completed a survey of their customer records and determined a total of 12,306 units were installed from January of 1994 through December of 1997. 7,601 units were originally sold to 767 US accounts and 4,705 units were sold to 102 international accounts. The firm estimates approximately 3000 units worldwide are still in operation with the Revision M or earlier base.
  • Product Description
    Ultraview Universal Clinical Workstation System Model 90385.
  • Manufacturer
    Spacelabs Medical Incorporated

Manufacturer

Spacelabs Medical Incorporated
  • Manufacturer Address
    Spacelabs Medical Incorporated, 5150 220th Ave Se, Issaquah WA 98029-6834
  • Source
    USFDA