Recall Z-0834-2014— DeRoyal Industries Inc
Class II · Terminated
Class II FDA medical device recall by DeRoyal Industries Inc, initiated 2013-09-17, terminated 2017-06-05. FDA's recall record names no specific 510(k) clearance for this event. Product: Aquarius (TM) TEMPERATURE THERAPY, REF T650, Rx Only, Manufactured for DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, Made in China. Physical Therapy.. Reason: 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..
- Recalling firm
- DeRoyal Industries Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-09-17
- Terminated
- 2017-06-05
- Firm location
- New Tazewell, TN, United States
Product description
Aquarius (TM) TEMPERATURE THERAPY, REF T650, Rx Only, Manufactured for DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, Made in China. 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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.