Events

Recall of Device Recall Aruba Wireless Access Points, Model 65

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
    58978
  • Event Risk Class
    Class 2
  • Event Number
    Z-2918-2011
  • Event Initiated Date
    2011-05-16
  • Event Date Posted
    2011-08-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-08-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100762
  • 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
    Cardiovascular (Arrythmia) Detector and Alarm System - Product Code DSI
  • Reason
    Aruba wireless network access points, model number 65, experienced a higher than expected incidence of dropouts due to external rf interference.
  • Action
    Welch Allyn Protocol, Inc. sent a letter dated May 16, 2011 to affected customer. The letter stated there were concerns over drop-outs in the system recommended the system at this hospital to revert back to the Symbol wireless infrastructure. For questions call Welch Allyn at 315-685-4100.

Device

Device Recall Aruba Wireless Access Points, Model 65
  • Model / Serial
    Model Number 65.   System Serial # TA00646 with TA01973, TA00668, TA00668-HA, TA00823, TA00823-HA, TA01968, TA01969, TA01970, TA01971, TA01972, TA01974, TA01975, TA02439, TA02444, and TA02444-HA.  The HA represents High Acuity and is a back-up system connected to the unit with the same number, except for TA00646 which is back up for TA01973. This unit did not originally have a back up and the other unit was not being used so they were combined. The numbers stayed the same for each system for tracking purposes.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: (USA) Nationwide distribution including the state of California; and the countries of Singapore; Philippines, France, Italy, Malaysia, Poland, UK, England, UAE, Germany, Spain, Ireland, Portugal, New Zealand, Hong Kong, Thailand, Australia, Canada, and the Netherlands.
  • Product Description
    Aruba Wireless Network Access Points, Model 65 utilized by the Acuity Central Monitoring System. || Welch Allyn Protocol, Inc. || Intended for use by clinicians for the central monitoring of neonatal, pediatric and adult patients in health care facilities. The system connects to a network of patient monitors to record and analyze physiological data being acquired by the monitors.
  • 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