Events

Recall of Device Recall Welch Allyn Vital Sign 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
    52721
  • Event Risk Class
    Class 2
  • Event Number
    Z-1873-2009
  • Event Initiated Date
    2009-07-28
  • Event Date Posted
    2009-07-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-08-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=83814
  • 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 Sign Monitor - Product Code MWI
  • Reason
    The welch allyn vsm300 vital signs monitor may experience a loss of audio which includes a loss of audio alarms.
  • Action
    An "Urgent: Correction" letter dated July 28, 2009 was sent to customers describing the risk associated with loss of audible alarms and recommend that the users mitigate the risk by checking for proper audible alarm function each time they power on the device. (Current labeling describes the variety of beeps and tones that should be present). Users were instructed: 1) if the audio fails, do not use the device, 2) Remove it from service and 3) contact Welch Allyn Protocol, Inc. at the following telephone number (1-800-289-2501) to arrange the return and repair of your device to Technical Services. Direct questions about this recall to Welch Allyn Protocol, Inc. by calling 1-503-530-7935.

Device

Device Recall Welch Allyn Vital Sign Monitor
  • Model / Serial
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- US, United Arab Emirates, Afghanistan, Austria, Australia, Belgium, Bulgaria, Bahrain, Botswana, Canada, Switzerland, China, Cyprus, Germany, Denmark, Egypt, Spain, Figi, France, Great Britain, Greece, Hong Kong, Croatia, Indonesia, Ireland, Israel, India, Iceland, Italy, Jordan, Kenya, Kyrgyzstan, South Korea, Kuwait, Lebanon, Sri Lanka, Malaysia, Nigeria, The Netherlands, Norway, New Zealand, Oman, Phillipines, Pakistan, Poland, Puerto Rico, Panama, Portugal, Qatar, Russia, Saudi Arabia, Sweden, Singapore, Thailand, Taiwan and South Africa.
  • Product Description
    Welch Allyn Vital Sign Monitor 5300 Series/Class II. (VSM 300). || The VSM300 can monitor systolic and diastolic noninvasive blood pressure (NIBP), pulse rate, and mean arterial pressure (MAP). Units configured with the appropriate options can also simultaneously monitor temperature and noninvasive functional oxygen saturation of arteriolar hemoglobin (SpO2), and continuously monitor pulse rate. The monitor provides programmable audible and visual alarms and automatic NIBP measurements at selectable intervals.
  • 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