FDA-Device2015-02-18Class II
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.
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.
Sold states
US Nationwide Distribution
Affected count
928 units
Manufactured in
2568 Bristol Circle, N/A, Oakville, Ontario, Canada
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1068-2015Don't want to check this manually?
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