The Recall Desk

FDA (Devices) recall action 81418

GE Healthcare, LLC recalled 2 products on 2018-11-14

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
2018-11-14
Critical
0
Units
86

Why these products were recalled

Synchronization failure

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)··2018-11-14

    GE Healthcare Recalls Centricity Universal Viewer Due to Synchronization Failure

    GE Healthcare is recalling 73 Centricity Universal Viewer units because a synchronization failure may affect the display of medical images.

    Product
    Centricity Universal Viewer with PACS-IW foundation 6.0.x displays medical images (including mammograms) and data from various imaging sources.
    Category
    Distribution
    13 states
  • ModerateFDA (Devices)··2018-11-14

    GE Healthcare Recalls Centricity PACS-IW Software Due to Synchronization Failure

    GE Healthcare is recalling 13 units of Centricity PACS-IW software due to a synchronization failure that may affect the display of medical images.

    Product
    Centricity PACS-IW with Universal Viewer version 5.0.x with PACS-IW foundation displays medical images (including mammograms) and data from various imaging sources.
    Category
    Distribution
    13 states