05
Feb
2014

Cl II DeRoyal Aquarius Therapy Units

0

Company: DeRoyal Industries Inc
Date of Enforcement Report:2/5/2014
Class lI:

PRODUCT

1. Aquarius (TM) TEMPERATURE THERAPY, REF T650, Rx Only, Manufactured for DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, Made in China._x000D_ _x000D_ Physical Therapy. Recall Number Z-0834-2014

2. 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._x000D_ _x000D_ Physical Therapy. Recall Number Z-0835-2014

3. DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Knee/Shoulder Blnkt NS, REF T653NS, Rx only, Manufacturer DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849._x000D_ _x000D_ Physical Therapy. Recall Number Z-0836-2014

4. DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Knee Blanket w/ Straps NS, REF T654NS, Rx only, Manufacturer DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849._x000D_ _x000D_ Physical Therapy. Recall Number Z-0837-2014

5. DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Shoulder Blanket w/ Straps NS, REF T655NS, Rx only, Manufacturer DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849._x000D_ _x000D_ Physical Therapy. Recall Number Z-0838-2014

6. 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._x000D_ _x000D_ Physical Therapy. Recall Number Z-0839-2014

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/MANUFACTURER
DeRoyal Industries Inc., New Tazewell on 9/17/2013. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
1. 738 units
2. 121 units
3. 409 units
4. 48 units
5. 2 units
6. 25 units

DISTRIBUTION
Nnationwide

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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