The Recall Desk
SevereFDA (Devices)·Z-0834-2014·Announced 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.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves reports of electric shock, which constitutes significant injury reports under the severity rubric.

Plain-English summary

DeRoyal Industries, Inc. is recalling 738 units of the Aquarius (TM) Temperature Therapy device, reference T650. The units were distributed nationwide. The recall affects specific lot numbers, including 31480713, 31480721, and 31968743.

The recall is due to a defect where the unit displays an error code for hose kinking when no kink is present. Additionally, the unit fails to monitor and control the temperature of the water in the blanket as intended. This failure could result in temperature injuries to the treatment site. There have also been two reports of electric shock associated with the device.

Consumers should stop using the affected units immediately. The product is prescription-only and was manufactured for DeRoyal Industries, Inc. in China.

The recalled product

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.
Manufacturer
DeRoyal Industries Inc
Category
Medical Device — Physical Therapy
Hazard
Affected units
738

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (18)

  • Lot Numbers: 31480713
  • 31480721
  • 31968743
  • 31971619
  • 31990844
  • 32005711
  • 32018491
  • 32037764
  • 32118020
  • 32710832
  • 32736223
  • 33053264
  • 33105221
  • 33141176
  • 33164204
  • 33164407
  • 33276273
  • 33329911

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 6 recalled by DeRoyal Industries Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 6 products in this recall →

Related recalls

Same manufacturer · DeRoyal Industries Inc

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Same hazard · temperature injury

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