EPWorks software used in the Xltek Protektor Stimulator Product Usage: Intraoperative diagnosis of acute dysfunction in
FDA device recall Z-1068-2015 · posted 2015-02-09 · Terminated
Recall details
- Recalling firm
- Natus Medical Incorporated
- 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.
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- GWF
- Quantity affected
- 928 units
- Distribution
- US Nationwide Distribution
- Date initiated
- 2015-01-02
- Date posted
- 2015-02-09
- Date terminated
- 2017-03-22
- Location
- Oakville Canada, Ontario
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| XLTEK PROTEKTOR STIMULATOR, MODELS 10247 & 10248 (K040358) | Excel Tech. , Ltd. | 2004-08-06 |