Recall Z-1068-2015
Natus Medical Incorporated · initiated January 2, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: EPWorks Software Versions prior to 6.0
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.
FDA-determined cause: Software design
Action taken
Natus Medical Inc. DBA Excel-Tech Ltd (Xltek) issued medical device notification letters dated December 22, 2014 to their customers vial email and via courier service on January 2, 2015. Within the notice, customers are instructed are on to removal the previous installation and also on how to install the new program upgrade. Natus Medical Inc. has requested that the Previous Version Removed from Use Confirmation form be completed by each customer and returned. Customers who require assistance can contact Natus Technical service by calling 800-387-7516 or via email Oakville_Technical_Service@xltek.com or ots@natus.com.
Details
- Recall number
- Z-1068-2015
- Initiated
- January 2, 2015
- Posted by FDA
- February 9, 2015
- Terminated
- March 22, 2017
- Product code
- GWF – Stimulator, Electrical, Evoked Response
- Quantity
- 928 units
- Distribution
- US Nationwide Distribution
- Recalling firm
- Natus Medical Incorporated, Oakville Canada, Ontario
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1067-2015 Class II | EPWorks software used in the Protektor 32 Product Usage: Uses electroencephalography…Software error occurs when using remote monitoring; if the remote user tries to stop the free run waveform… | 01/02/2015Terminated |