Recall Z-0839-2014
DeRoyal Industries Inc · initiated September 17, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: Lot Numbers: 32901129, 32980912, 33015541, 33024746, 33105239
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: Device Design
Action taken
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.
Details
- Recall number
- Z-0839-2014
- Initiated
- September 17, 2013
- Posted by FDA
- January 27, 2014
- Terminated
- June 5, 2017
- Product code
- ILO – Pack, Hot Or Cold, Water Circulating
- Quantity
- 25 units
- Distribution
- Nationwide Distribution.
- Recalling firm
- DeRoyal Industries Inc, New Tazewell, TN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0834-2014 Class II | Aquarius (TM) TEMPERATURE THERAPY, REF T650, Rx Only, Manufactured for DeRoyal…The unit displays an error code of hose kinking when no hose kink is present; the unit fails to monitor the… | 09/17/2013Terminated |
| Z-0835-2014 Class II | DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Knee/Shoulder Blanket NS, REF…The unit displays an error code of hose kinking when no hose kink is present; the unit fails to monitor the… | 09/17/2013Terminated |
| Z-0836-2014 Class II | DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Knee/Shoulder Blnkt NS, REF T653NS…The unit displays an error code of hose kinking when no hose kink is present; the unit fails to monitor the… | 09/17/2013Terminated |
| Z-0837-2014 Class II | DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Knee Blanket w/ Straps NS, REF…The unit displays an error code of hose kinking when no hose kink is present; the unit fails to monitor the… | 09/17/2013Terminated |
| Z-0838-2014 Class II | DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Shoulder Blanket w/ Straps NS, REF…The unit displays an error code of hose kinking when no hose kink is present; the unit fails to monitor the… | 09/17/2013Terminated |