FDAFDA · Food and drugs·Recall number Z-0839-2014
DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Foot/Ankle Blanket NS, REF T656NS, Rx only, Manufacturer DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849. Physical Therapy.
Published February 5, 2014 · Recall initiated: September 17, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- DeRoyal Industries Inc
- Distributor
- Nationwide Distribution.
- Lot
- Lot Numbers: 32901129, 32980912, 33015541, 33024746, 33105239
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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