The Recall Desk

FDA (Devices) recall action 83036

GE Healthcare, LLC recalled 2 products on 2019-07-03

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
2019-07-03
Critical
0
Units
342

Why these products were recalled

There is a potential that one or more images or image series may be missing from exams without a warning displayed in the viewer.

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

  • HighFDA (Devices)··2019-07-03

    GE Healthcare Recalls Centricity Universal Viewer for Missing Image Warning

    GE Healthcare is recalling 292 units of the Centricity Universal Viewer because it may fail to warn users when medical images are missing from exams.

    Product
    Centricity Universal Viewer with PACS-IW foundation 6.0, Model number 2090255-001 Product Usage: 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, com
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2019-07-03

    GE Healthcare Recalls Centricity PACS-IW Universal Viewer Software

    GE Healthcare is recalling Centricity PACS-IW with Universal Viewer version 5.0 because medical images may be missing without warning.

    Product
    Centricity PACS-IW with Universal Viewer version 5.0, Model Number 2068177-001 Product Usage: Centricity Universal Viewer is a device that displays medical images and data from various imaging sources, and from other healthcare information sources. Medical images and data can
    Category
    Distribution
    0 states