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Natus Medical Incorporated recalls EPWorks software used in the Xltek Protektor Stimulator Product Usage: Intraoperative diagnosis of acute dysfunction
Recalled February 18, 2015 · FDA recall Z-1068-2015 · Natus Medical Incorporated
Hazard
Software error occurs when using remote monitoring; if the remote user tries to stop the free run waveform group, the system will display a message informing the user that they do not have sufficient privilege. · FDA Class II
Units
928 units
Sold at
US Nationwide Distribution
Description
Software error occurs when using remote monitoring; if the remote user tries to stop the free run waveform group, the system will display a message informing the user that they do not have sufficient privilege.
Product
EPWorks software used in the Xltek Protektor Stimulator Product Usage: Intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction brought about by mechanical trauma (traction, shearing, laceration, or compression) or vascular insufficiency.
Manufacturer(s)
Natus Medical Incorporated
Made in
Canada
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →