Recalls / —

—#123231

Product

DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Knee/Shoulder Blanket NS, REF T652NS, Rx only, Manufacturer DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849. Physical Therapy.

FDA product code

ILO — Pack, Hot Or Cold, Water Circulating

Device class

Class 2

Medical specialty

Physical Medicine

Affected lot / code info

Lot Numbers: 32871821, 32976471, 33105247

Why it was 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.

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm

DeRoyal Industries Inc

Address

1595 Highway 33 S, New Tazewell, Tennessee 37825-7105

Distribution

Distribution pattern

Nationwide Distribution.

Timeline

Recall initiated

2013-09-17

Posted by FDA

2014-01-27

Terminated

2017-06-05

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #123231. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.