Class II — Natus Medical Incorporated
| Recalling firm | Natus Medical Incorporated |
|---|---|
| Registered facility | View this company's 4 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| 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. |
| Quantity | 928 units |
| Distribution | US Nationwide Distribution |
| Initiated | 2015-01-02 |
| Classified | 2015-02-09 |
| Terminated | 2017-03-22 |
| Recall number | Z-1068-2015 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Natus Medical Incorporated (Z-1068-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/70157/
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