Agency classClass IIOur severity:Severe FDA (Devices)·Z-0837-2014·Announced 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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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 48 units of the DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Knee Blanket w/ Straps NS, REF T654NS. The affected units were distributed nationwide. The recall involves specific lot numbers: 32871775, 32980891, 33132755, 33141184, 33217572, and 33329945.

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 who have this product should stop using it immediately and contact DeRoyal Industries, Inc. for instructions on how to return the unit or obtain a replacement.

The recalled product

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.
Manufacturer: DeRoyal Industries Inc
Category: Medical Device — Physical Therapy
Hazard: burn-injury
electric-shock
Affected units: 48

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 (6)

Lot Numbers: 32871775
32980891
33132755
33141184
33217572
33329945

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 →

Same manufacturer · DeRoyal Industries Inc

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