Natus Medical product recalled over laceration hazard

Recall date

January 2, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Natus Medical Incorporated recalls EPWorks software used in the Xltek Protektor Stimulator Product Usage: Intraoperative diagnosis of acute dysfunction in…

Recall number

Z-1068-2015

FDA classification

Class II

Brand / firm

Natus Medical Incorporated

Sold / distributed

US Nationwide Distribution

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.