PlainRecalls
FDA Devices Moderate Class II Terminated

DeRoyal (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.

Reported: February 5, 2014 Initiated: September 17, 2013 #Z-0836-2014

Product Description

DeRoyal (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.

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.

Details

Recalling Firm
DeRoyal Industries Inc
Units Affected
409 units
Distribution
Nationwide Distribution.
Location
New Tazewell, TN

Frequently Asked Questions

What product was recalled?
DeRoyal (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.. Recalled by DeRoyal Industries Inc. Units affected: 409 units.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on February 5, 2014. Severity: Moderate. Recall number: Z-0836-2014.