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.
Reported: February 18, 2015 Initiated: January 2, 2015 #Z-1068-2015
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.
Details
- Recalling Firm
- Natus Medical Incorporated
- Units Affected
- 928 units
- Distribution
- US Nationwide Distribution
- Location
- Oakville, Ontario
Frequently Asked Questions
What product 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.. Recalled by Natus Medical Incorporated. Units affected: 928 units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 18, 2015. Severity: Moderate. Recall number: Z-1068-2015.
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