The Recall Desk

FDA (Devices) recall action 72472

GE Healthcare recalled 2 products on 2015-11-11

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
2015-11-11
Critical
0
Units
—

Why these products were recalled

Inaccurate distance measurements with magnified projection X-ray images.

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

States named across these recalls

1–2 of 2

  • HighFDA (Devices)··2015-11-11

    GE Healthcare Recalls Centricity Universal Viewer Due to Inaccurate X-ray Measurements

    GE Healthcare is recalling Centricity Universal Viewer versions 6.0 and higher because magnified projection X-ray images may display inaccurate distance measurements.

    Product
    The Centricity Universal Viewer Version is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, communicated, processed and displayed within the system or across computer networks at distributed locatio
    Category
    Distribution
    26 states
  • HighFDA (Devices)··2015-11-11

    GE Healthcare Recalls Centricity PACS-IW Due to Inaccurate X-Ray Measurements

    GE Healthcare is recalling Centricity PACS-IW software because it may display inaccurate distance measurements for magnified projection X-ray images.

    Product
    The Centricity PACS-IW with Universal Viewer is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, communicated, processed and displayed within the system or across computer networks at distributed lo
    Category
    Distribution
    26 states