Events

Recall of Ultraview Universal Clinical Workstation Model 90385.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Spacelabs Medical 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
    29038
  • Event Risk Class
    Class 2
  • Event Number
    Z-1007-04
  • Event Initiated Date
    2004-05-07
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-04-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=33021
  • 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
    Detector And Alarm, Arrhythmia - Product Code DSI
  • Reason
    Potential for telemetry channels to drop off display.
  • Action
    For all US customers, a Medical Device Correction letter was mailed on May 7, 2004 via courier instructing their customers to insure all monitored patients are displayed. The letter also instructed customers to move the printer to another central monitor as well as having a Field Service Engineer install new software when it becomes available. This letter was also mailed to international customers on May 14, 2004.

Device

Ultraview Universal Clinical Workstation Model 90385.
  • Model / Serial
    serial numbers 385-3xxxxx or higher
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The firm distributes to hospitals nationwide. The firm also distributes to distributors internationally.
  • Product Description
    Ultraview Universal Clinical Workstation Model 90385.
  • Manufacturer
    Spacelabs Medical Inc.

Manufacturer

Spacelabs Medical Inc.
  • Manufacturer Address
    Spacelabs Medical Inc., 5150 220th Ave Se, Issaquah WA 98029
  • Source
    USFDA