Z-1068-2015 Class II Terminated
FDA device recall Z-1068-2015 was initiated by Natus Medical Incorporated on January 2, 2015 and is designated Class II. 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 … The recall status is terminated (terminated March 22, 2017). Affected quantity: 928 units.
Recall Details
- Product Type
- Devices
- Report Date
- February 18, 2015
- Initiation Date
- January 2, 2015
- Termination Date
- March 22, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 928 units
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.
Distribution Pattern
US Nationwide Distribution
Code Information
EPWorks Software Versions prior to 6.0