Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported February 18, 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.
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…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Natus Medical Incorporated recalled EPWorks software used in the Xltek Protektor Stimulator Product Usage: Intraoperative… - a moderate-severity action.
EPWorks software used in the Xltek Protektor Stimulator Product Usage: Intraoperative… was recalled by Natus Medical Incorporated in February 18, 2015. Reason: Software error occurs when using remote monitoring; if the remote user tries to stop the free run waveform gr…. Check the official notice for the remedy. Verify recall #Z-1068-2015 with the FDA Devices before acting.
The recall
Natus Medical Incorporated issued this moderate-severity FDA Devices recall-Software error occurs when using remote monitoring; if the remote user tries to stop the free run waveform gr….
- Moderate
- severity level
- 928 units
- affected scope
- Class II
- classification
- February 18, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1068-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1068-2015) was formally reported on February 18, 2015, with the manufacturer initiating the action on January 2, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. Natus Medical Incorporated is listed as the recalling firm, operating out of Oakville, Ontario. Federal records list the affected scope as 928 units.
The documented reason for this recall is: 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. Distribution data in the federal record shows the product reached: US Nationwide Distribution. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
928 units
Related Recalls
6
3 from same agency
Product description
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1068-2015 |
| Date reported | February 18, 2015 |
| Date initiated | January 2, 2015 |
| Recalling firm | Natus Medical Incorporated |
| Firm location | Oakville, Ontario |
| Affected scope | 928 units |
| Distribution | US Nationwide Distribution |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1068-2015) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Natus Medical Incorporated. Units affected: 928 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 18, 2015. Severity: Moderate. Recall number: Z-1068-2015.
Where was the recalled product distributed? ▼
Distribution: US Nationwide Distribution.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1068-2015) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported February 18, 2015. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.