Recall Z-1068-2015— Natus Medical Incorporated

Name: FDA recall Z-1068-2015
Creator: U.S. Food and Drug Administration
Published: 2015-01-02

Class II · Terminated

Class II FDA medical device recall by Natus Medical Incorporated, initiated 2015-01-02, terminated 2017-03-22. It names one FDA 510(k) clearance: K040358. 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.. 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: Natus Medical Incorporated
Classification: Class II
Status: Terminated
Initiated: 2015-01-02
Terminated: 2017-03-22
Firm location: Oakville, Ontario, Canada

510(k) clearances named in this recall

1 on FDA's record

K040358 — XLTEK PROTEKTOR STIMULATOR, MODELS 10247 & 10248Excel Tech. , Ltd.·cleared 2004-08-06

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.