Events

Recall of Device Recall Clinician Workstation

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Baxter Healthcare Corp..

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
    31467
  • Event Risk Class
    Class 2
  • Event Number
    Z-0981-05
  • Event Initiated Date
    2005-03-10
  • Event Date Posted
    2005-07-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-02-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=37948
  • 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
    Medical Computers And Software - Product Code LNX
  • Reason
    The medication administration results displayed in the 'view results' link may be inaccurate.
  • Action
    Urgent Device Correction recall letters dated 3/10/05 were sent to the direct accounts on the same date via first class mail. The letter describes the inaccuracies in the 'View Results' program, and informed the accounts that inaccurate information could lead to incorrect clinical decision-making, which could impact a patient''s medication treatment protocol. The accounts were requested to disable the 'View Results' link until a software upgrade is available, and to inform all clinical point of care users that the 'View Results' has been disabled and that the Manual Adminstration Record is to be used as the primary source of information for reviewing medication adminstration results. The accounts were instructed to contact their account executive and/or the Client Support Services at 1-877-835-2727 for instructions on how to disable the 'View Results' feature.

Device

Device Recall Clinician Workstation
  • Model / Serial
    Product code 2M5042, software versions 3.4, 4.0 and 4.1
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    Unclassified
  • Implanted device?
    No
  • Distribution
    Missouri, Massachusetts, Vermont, California and Canada.
  • Product Description
    Clinician Workstation Software, product code 2M5042
  • Manufacturer
    Baxter Healthcare Corp.

Manufacturer

Baxter Healthcare Corp.
  • Manufacturer Address
    Baxter Healthcare Corp., Rt. 120 & Wilson Rd, Round Lake IL 60073
  • Source
    USFDA