DeRoyal—Aquarius Hot/Cold Therapy Units Used with Various Blankets: May Not Control Temperature; May Cause Electrical Shock
February 19, 2014 | Risk Management News
ECRI Institute’s complete weekly summary of medical device hazard and recall information is available in ECRI Institute’s Health Devices Alerts(HDA). For more information about HDA, contact us at firstname.lastname@example.org.
FDA's Center for Devices and Radiological Health (CDRH) states that the systems below may display an error code of hose kinking when no hose kink is present, potentially resulting in the unit failing to monitor the temperature of the water and controlling it through the automatic temperature control. This problem may result in temperature injuries to the treatment site. FDA's CDRH also states that there have been 2 reports of electric shock. FDA's CDRH further states that the manufacturer initiated a recall by Urgent Voluntary Recall Deroyal Hot/Cold Therapy Unit letter dated September 17, 2013. The manufacturer has not confirmed the...