The Recall Desk

FDA (Devices) recall action 77198

Nexstim PLC recalled 2 products on 2017-06-14

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
2017-06-14
Critical
0
Units
32

Why these products were recalled

Software defect: the NBS software may accidentally generate duplicate copies of one or several files.

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.

States named across these recalls

1–2 of 2

  • ModerateFDA (Devices)··2017-06-14

    Nexstim eXima NBS System Software Recalled for File Duplication Defect

    Nexstim PLC is recalling 11 units of the eXima NBS System due to a software defect that may generate duplicate files.

    Product
    Nexstim eXima NBS System Software version 2.2 or higher. The Nexstim Navigated Brain Stimulation System (NBS System) is indicated for noninvasive mapping of the primary motor cortex of the brain to its cortical gyrus. The NBS System provides information that may be used in the a
    Category
    Distribution
    1 state
  • ModerateFDA (Devices)··2017-06-14

    Nexstim Navigated Brain Stimulation System Software Defect Recall

    Nexstim PLC is recalling 21 units of the Navigated Brain Stimulation System due to a software defect that may generate duplicate files.

    Product
    NBS System 4 (sw version 4.0 or higher), Software update to 4.3.3 and NBS System 5 (sw version 5.0 or higher), Software update to 5.1.1. The Nexstim Navigated Brain Stimulation System (NBS System) is indicated for noninvasive mapping of the primary motor cortex of the brain to i
    Category
    Distribution
    1 state