The Recall Desk

FDA (Devices) recall action 70157

Natus Medical Incorporated recalled 2 products on 2015-02-18

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2015-02-18
Critical
0
Units
1,176

Why these products were 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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • ModerateFDA (Devices)··2015-02-18

    Natus Medical Recalls EPWorks Software Due to Remote Monitoring Error

    Natus Medical is recalling EPWorks software versions prior to 6.0 used in the Xltek Protektor Stimulator. A software error prevents remote users from stopping free run waveform groups.

    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.
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2015-02-18

    Natus Medical Recalls EPWorks Software Due to Remote Monitoring Error

    Natus Medical is recalling EPWorks software versions prior to 6.0 because a software error prevents remote users from stopping free run waveform groups.

    Product
    EPWorks software used in the Protektor 32 Product Usage: Uses electroencephalography (EEG), evoked potentials (EP), electromyography (EMG) and transcranial motor evoked potentials (TcMEP) stimulation techniques to provide healthcare professionals with information to help asse
    Category
    Distribution
    0 states