| Class 2 Device Recall DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Knee Blanket w/ Straps | |
Date Initiated by Firm | September 17, 2013 |
Date Posted | January 27, 2014 |
Recall Status1 |
Terminated 3 on June 05, 2017 |
Recall Number | Z-0837-2014 |
Recall Event ID |
66742 |
Product Classification |
Pack, hot or cold, water circulating - Product Code ILO
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Product | DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Knee Blanket w/ Straps NS, REF T654NS, Rx only, Manufacturer DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849.
Physical Therapy. |
Code Information |
Lot Numbers: 32871775, 32980891, 33132755, 33141184, 33217572, 33329945 |
Recalling Firm/ Manufacturer |
DeRoyal Industries Inc 1595 Highway 33 S New Tazewell TN 37825-7105
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For Additional Information Contact | Tracy 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 |
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 | 48 units |
Distribution | Nationwide Distribution. |
Total Product Life Cycle | TPLC Device Report |
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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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