Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1068-2015 — 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.

U.S. FDA — Device Enforcement · Canada · 2015-01-02 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1068-2015
Date of alert: 2015-01-02
Country / jurisdiction: Canada
Risk level: Class II
Risk type: recall
Brand: Natus Medical Incorporated
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

Recall Z-1068-2015 — 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.

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