The Recall Desk

FDA (Devices) recall action 64783

Philips And Neusoft Medical Systems Co., Ltd. recalled 2 products on 2013-05-01

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
2013-05-01
Critical
0
Units
48

Why these products were recalled

User error of the NeuViz 16 or NeuViz Dual may cause personnel injuries. There was a report where a finger was pinched when the table was moved backward while the tabletop was controlled by another person from the gantry left control panel.

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

  • HighFDA (Devices)··2013-05-01

    Philips NeuViz 16 CT Scanner Recalled Due to Pinch Hazard

    Philips and Neusoft are recalling 23 NeuViz 16 CT scanners because a user error could cause personnel injuries, including a reported finger pinch.

    Product
    NeuViz 16 Multi-Slice CT Scanner System, Part number (PN): 989605858501, Model: NeuViz 16. This is a computed X-ray, Tomography system. The NeuViz 16 CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube…
    Category
    Distribution
    8 states
  • HighFDA (Devices)··2013-05-01

    Philips NeuViz Dual CT Scanner Recalled for Pinch Hazard

    Philips and Neusoft are recalling 25 NeuViz Dual CT scanners because user error can cause personnel injuries, including a reported finger pinch.

    Product
    NeuViz Dual series CT Scanner System, Part number (PN): 989605651321. This is a computed X-ray, Tomography system. NeuViz Dual Multi-slice CT Scanner System is intended to produce cross-section images of head and body by computer reconstruction of X-ray transmission data…
    Category
    Distribution
    8 states