FDA (Devices) recall action 66742
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.
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.
DeRoyal Industries is recalling 2 units of the Aquarius Hot/Cold Therapy Combo Unit due to temperature monitoring failures and electric shock reports.
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.
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.
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.
DeRoyal Industries is recalling 48 Aquarius Hot/Cold Therapy Combo Units because they fail to monitor water temperature and have caused electric shocks.
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.