Company: Natus Medical Incorporated
Date of Enforcement Report 2/18/2015
Class lI:
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.
Recall Number Z-1068-2015
REASON
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.
RECALLING FIRM/MANUFACTURER
Natus Medical Incorporated, Oakville, ON, Canada on 1/2/2015. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
928 units
DISTRIBUTION
Nationwide.
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