Events

Recall of Device Recall Arial WaterResistant Pendant, model 59350

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Stanley Security Solutions 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
    76047
  • Event Risk Class
    Class 2
  • Event Number
    Z-1499-2017
  • Event Initiated Date
    2016-06-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-11-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152047
  • 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
    System, communication, powered - Product Code ILQ
  • Reason
    Devices were incorrectly programmed during manufacturing therefore depressing the pendant button may result in an alarm not sounding as intended.
  • Action
    Stanley Healthcare sent an Important Recall Notice dated June 22, 2016, to all affected customers. The notice instructed customers to discontinue use of the device and to contact the recalling firm to arrange for return of the device. The recalling firm also asked the customer to complete a response form indicating they read, understood and complied with the recall notice. Customers with questions were instructed to contact Arial Customer Service at 888-716-0077. For questions regarding this recall call 781-216-9035.

Device

Device Recall Arial WaterResistant Pendant, model 59350
  • Model / Serial
    Serial numbers WP149149 through WP149398 and WP149649 through WP149898.
  • Product Classification
    Physical Medicine Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution to AR, AZ, CA, FL, GA, IA, ID, IN, KS, MD, MN, MO, NC, NE, NJ, NY, OH, OR, PA, SD, UT, VA, and WI.
  • Product Description
    Arial Wireless Water-Resistant Call Pendant || The Arial Pendant tag is part of the Arial wireless emergency call management system. It enables residents in assisted living, skilled nursing or independent living to call staff with the press of a button.
  • Manufacturer
    Stanley Security Solutions Inc

Manufacturer

Stanley Security Solutions Inc
  • Manufacturer Address
    Stanley Security Solutions Inc, 4600 Vine St, Lincoln NE 68503-2823
  • Source
    USFDA