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U.S. Department of Health and Human Services

Class 2 Device Recall DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Knee/Shoulder Blnkt

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 Class 2 Device Recall DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Knee/Shoulder Blnktsee related information
Date Initiated by FirmSeptember 17, 2013
Date PostedJanuary 27, 2014
Recall Status1 Terminated 3 on June 05, 2017
Recall NumberZ-0836-2014
Recall Event ID 66742
Product Classification Pack, hot or cold, water circulating - Product Code ILO
ProductDeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Knee/Shoulder Blnkt NS, REF T653NS, Rx only, Manufacturer DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849. Physical Therapy.
Code Information Lot Numbers: 32901145, 33063999, 3132641, 3217556, 33276468, 33369411, 33412431, 33415413
Recalling Firm/
Manufacturer		 DeRoyal Industries Inc
1595 Highway 33 S
New Tazewell TN 37825-7105
For Additional Information ContactTracy Edmundson
865-362-2334
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
ActionDeRoyal 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 Commerce409 units
DistributionNationwide Distribution.
Total Product Life CycleTPLC 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.
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