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U.S. Department of Health and Human Services

Class 2 Device Recall Aquarius (TM) TEMPERATURE THERAPY

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  Class 2 Device Recall Aquarius (TM) TEMPERATURE THERAPY see related information
Date Initiated by Firm September 17, 2013
Date Posted January 27, 2014
Recall Status1 Terminated 3 on June 05, 2017
Recall Number Z-0834-2014
Recall Event ID 66742
Product Classification Pack, hot or cold, water circulating - Product Code ILO
Product Aquarius (TM) TEMPERATURE THERAPY, REF T650, Rx Only, Manufactured for DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, Made in China.

Physical Therapy.
Code Information Lot Numbers: 31480713, 31480721, 31968743, 31971619, 31990844, 32005711, 32018491, 32037764, 32118020, 32710832, 32736223, 33053264, 33105221, 33141176, 33164204, 33164407, 33276273, 33329911
Recalling Firm/
DeRoyal Industries Inc
1595 Highway 33 S
New Tazewell TN 37825-7105
For Additional Information Contact Tracy Edmundson
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
Device Design
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.
Quantity in Commerce 738 units
Distribution Nationwide Distribution.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.