Aquarius (TM) TEMPERATURE THERAPY, REF T650, Rx Only, Manufactured for DeRoyal Industries, Inc. 200 DeBusk Lane, Powell,
FDA device recall Z-0834-2014 · posted 2014-01-27 · Terminated
Recall details
- Recalling firm
- DeRoyal Industries Inc
- 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.
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- ILO
- Quantity affected
- 738 units
- Distribution
- Nationwide Distribution.
- Date initiated
- 2013-09-17
- Date posted
- 2014-01-27
- Date terminated
- 2017-06-05
- Location
- New Tazewell, TN
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