CLASS II Device recall · Reported 18 Feb 2015 · FDA Enforcement Report

EPWorks software used in the Xltek Protektor Stimulator Product recalled

Natus Medical is recalling EPWorks software used in the Xltek Protektor Stimulator Product, distributed nationwide in the US. The recall was initiated on 2 Jan 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesEPWorks Software Versions prior to 6.0

Quantity recalled928 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1068-2015
FDA event ID: 70157
Recalling firm: Natus Medical, Oakville, Ontario
Classification: Class II
Status: Terminated
Recall initiated: 2 Jan 2015
FDA classified: 9 Feb 2015
Reported: 18 Feb 2015
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Device Malfunction
Device type: Heart & Vascular Devices

Timeline

2 Jan 2015	Recall initiated by company
9 Feb 2015	Classified by FDA	+38 days
18 Feb 2015	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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.

Where it was distributed

US Nationwide Distribution

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

EPWorks Software Versions prior to 6.0

Where was it sold?

US Nationwide Distribution

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 70157

This product is part of a recall event; the main page for the event is EPWorks software used in the Protektor 32 Product Usage: Uses recalled.

Reported	Class	Recall	Company	Reason	Where
18 Feb 2015	CLASS II	EPWorks software used in the Protektor 32 Product Usage: Uses recalled	Natus Medical	Device Malfunction	Nationwide

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