Events

Recall of Propaq LT vital signs monitor

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Welch Allyn Protocol, 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
    36628
  • Event Risk Class
    Class 2
  • Event Number
    Z-0216-2007
  • Event Initiated Date
    2006-10-22
  • Event Date Posted
    2006-11-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-08-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49027
  • 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
    vital signs monitor - Product Code MWI
  • Reason
    Potential to burn patient's finger. a nellcor pulse oximetry (sp02) sensor became hot when used with a propaq lt.
  • Action
    A letter dated October 22, 2006 was sent to customers between October 25-27,2006. The letter advised of the problem and requested the customer contact the firm to arrange for return of the monitor to be serviced. The customer will be provided with a temporary replacement. The dealers were requested to notify their customers.

Device

Propaq LT vital signs monitor
  • Model / Serial
    KA001225 through KA002847
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Devices were distributed to hospitals/medical centers and dealers worldwide.
  • Product Description
    Propaq LT vital signs monitor, Model 802LTRN
  • Manufacturer
    Welch Allyn Protocol, Inc

Manufacturer

Welch Allyn Protocol, Inc
  • Manufacturer Address
    Welch Allyn Protocol, Inc, 8500 Sw Creekside Pl, Beaverton OR 97008
  • Manufacturer Parent Company (2017)
    Hill-Rom Holdings, Inc
  • Source
    USFDA