Events

Recall of Welch Allyn Vital Signs Monitor 5300 Series 300 || Part numbers 007-0098-00 through 007-0159-00

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
    29233
  • Event Risk Class
    Class 2
  • Event Number
    Z-1333-04
  • Event Initiated Date
    2004-06-08
  • Event Date Posted
    2004-08-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-06-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=33369
  • 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
    Oximeter - Product Code DQA
  • Reason
    Potential speaker failure could result in absence of audible annunciation of pulse tones, patient alarms and equipment alerts.
  • Action
    The firm contacted their customers and their distributors customers via letters dated June 8, 2004 through July 9, 2004. The letters instruct their customers to verify speaker functionality. If the customers do not hear two quick beeps or there is static then they have a faulty speaker. The letters instruct them to stop using the monitor and contact Welch Allyn to have the monitor repaired. If the monitor continues to emit two quick beeps their customers are to contact Welch Allyn to have the monitor repaired as soon as it is convenient. The customers are to verify the two beeps prior to each use. The letter dated June 8, 2004 went to only a couple of direct customers. The remaining letters dated June 14, 2004, June 23, 2004, June 30, 2004 and July 9, 2004 went to direct customers, distributors and distributors'' end user customers.

Device

Welch Allyn Vital Signs Monitor 5300 Series 300 || Part numbers 007-0098-00 through 007-0159-00
  • Model / Serial
    Serial numbers JA000225 through JA002052.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Welch Allyn distributes product to hospitals, physicians and distributors nationwide and internationally.
  • Product Description
    Welch Allyn Vital Signs Monitor 5300 Series 300 || Part numbers 007-0098-00 through 007-0159-00
  • Manufacturer
    Welch Allyn Protocol, Inc

Manufacturer

Welch Allyn Protocol, Inc
  • Manufacturer Address
    Welch Allyn Protocol, Inc, 8500 SW Creekside Pl, Beaverton OR 97008-7107
  • Source
    USFDA