EPWorks software used in the Xltek Protektor Stimulator recall: Software Issue
EPWorks software used in the Xltek Protektor Stimulator Product Usage: Intraoperative diagnosis of acute dysfunction in corticospinal axonal…
Why was EPWorks software used in the Xltek Protektor Stimulator 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
EPWorks Software Versions prior to 6.0
- Product
- EPWorks software used in the Xltek Protektor Stimulator Product Usage: Intraoperative diagnosis of acute dysfunction in corticospinal axonal…
- Recalling firm
- Natus Medical Incorporated
- Quantity
- 928 units
- Distribution
- US Nationwide Distribution
- Recall date
- February 18, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)