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.
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 a significant injury report under the severity rubric.
Plain-English summary
DeRoyal Industries, Inc. is recalling two units of the DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Shoulder Blanket w/ Straps NS, REF T655NS. The affected units are identified by Lot Number 32871812 and were distributed nationwide.
The recall is due to a defect where the unit displays a false error code for hose kinking and fails to monitor or control the water temperature in the blanket as intended. This malfunction could result in temperature injuries to the treatment site. Additionally, there have been two reports of electric shock associated with the device.
Consumers who possess this specific product should stop using it immediately and contact DeRoyal Industries, Inc. for instructions on return or replacement.
The recalled product
- 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.
- Manufacturer
- DeRoyal Industries Inc
- Affected units
- 2
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 (1)
- Lot Number: 32871812
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.
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