Events

Recall of Aquarius (TM) TEMPERATURE THERAPY

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by DeRoyal Industries 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
    66742
  • Event Risk Class
    Class 2
  • Event Number
    Z-0834-2014
  • Event Initiated Date
    2013-09-17
  • Event Date Posted
    2014-01-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-06-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=123230
  • 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
    Pack, hot or cold, water circulating - Product Code ILO
  • Reason
    The unit displays an error code of hose kinking when no hose kink is present; the unit fails to monitor the temperature of the water in the blanket as intended and controlling it through the automatic temperature control. this failure could result in temperature injuries to the treatment site; and there have been two reports of electric shock.
  • Action
    DeRoyal sent a "URGENT VOLUNTARY RECALL DEROYAL HOT/COLD THERAPY UNIT" letter dated September 17, 2013. The letter identified the product, problem, and actions to be taken by the customers.

Device

Aquarius (TM) TEMPERATURE THERAPY
  • Model / Serial
    Lot Numbers: 31480713, 31480721, 31968743, 31971619, 31990844, 32005711, 32018491, 32037764, 32118020, 32710832, 32736223, 33053264, 33105221, 33141176, 33164204, 33164407, 33276273, 33329911
  • Product Classification
    Physical Medicine Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution.
  • Product Description
    Aquarius (TM) TEMPERATURE THERAPY, REF T650, Rx Only, Manufactured for DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, Made in China. || Physical Therapy.
  • Manufacturer
    DeRoyal Industries Inc

Manufacturer

DeRoyal Industries Inc
  • Manufacturer Address
    DeRoyal Industries Inc, 1595 Highway 33 S, New Tazewell TN 37825-7105
  • Manufacturer Parent Company (2017)
    Deroyal Industries Inc.
  • Source
    USFDA