The Recall Desk

FDA (Devices) recall action 66742

DeRoyal Industries Inc recalled 6 products on 2014-02-05

The FDA (Devices) publishes a recall like this one as 6 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 6 pages.

Products
6
Announced
2014-02-05
Critical
0
Units
1,343

Why these products were recalled

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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–6 of 6

  • SevereFDA (Devices)··2014-02-05

    DeRoyal Aquarius Hot/Cold Therapy Unit Recalled for Temperature Control Failure

    DeRoyal Industries is recalling 25 Aquarius Hot/Cold Therapy Combo Units because they fail to monitor water temperature, posing a risk of temperature injuries and electric shock.

    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.
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2014-02-05

    DeRoyal Aquarius Temperature Therapy Units Recalled for Temperature Control Failure

    DeRoyal Industries is recalling 738 Aquarius Temperature Therapy units because they fail to monitor water temperature, posing a risk of temperature injuries and electric shock.

    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.
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2014-02-05

    DeRoyal Aquarius Hot/Cold Therapy Unit Recalled for Temperature Control Failure

    DeRoyal Industries is recalling 2 units of the Aquarius Hot/Cold Therapy Combo Unit due to temperature monitoring failures and electric shock reports.

    Product
    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. Physical Therapy.
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2014-02-05

    DeRoyal Aquarius Hot/Cold Therapy Unit Recalled for Temperature and Shock Risks

    DeRoyal Industries is recalling 48 Aquarius Hot/Cold Therapy Combo Units because they fail to monitor water temperature and have caused electric shocks.

    Product
    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. Physical Therapy.
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2014-02-05

    DeRoyal Aquarius Hot/Cold Therapy Unit Recalled for Temperature Control Failure

    DeRoyal Industries is recalling 121 Aquarius Hot/Cold Therapy Combo Units because they fail to monitor water temperature, posing a risk of temperature injuries and electric shock.

    Product
    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. Physical Therapy.
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2014-02-05

    DeRoyal Aquarius Hot/Cold Therapy Unit Recalled for Temperature Control Failure

    DeRoyal Industries is recalling 409 Aquarius Hot/Cold Therapy Combo Units because they fail to monitor water temperature, posing a risk of temperature injuries and electric shock.

    Product
    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. Physical Therapy.
    Category
    Distribution
    0 states