EPWorks software used in the Xltek Protektor Stimulator Product… — Class II medical device recall Z-1068-2015
Terminated recall by Natus Medical Incorporated, reported 2015-02-18, distributed nationwide. Software error occurs when using remote monitoring; if the remote user tries to stop the free run waveform gro
| Recall number | Z-1068-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Natus Medical Incorporated, Oakville, Ontario, Canada |
| Recall initiated | 2015-01-02 |
| Classified | 2015-02-09 |
| Reported by FDA | 2015-02-18 |
| Terminated | 2017-03-22 |
| Distributed | Nationwide (US) |
| Quantity | 928 units |
| Reason classes | software |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1068-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.