The Recall Desk

FDA (Devices) recall action 82668

GE Healthcare, LLC recalled 5 products on 2019-06-19

The FDA (Devices) publishes a recall like this one as 5 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 5 pages.

Products
5
Announced
2019-06-19
Critical
0
Units
—

Why these products were recalled

There has been a reported incident of a Distar CRT monitor that has fallen off the monitor wall mount related to product aging.

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

States named across these recalls

1–5 of 5

  • ModerateFDA (Devices)··2019-06-19

    GE Healthcare Precision 500D X-ray System Recall for Monitor Mount Failure

    GE Healthcare is recalling Precision 500D X-ray systems because a CRT monitor fell off its wall mount due to product aging.

    Product
    Precision 500D The Precision 500D R&F X-ray System is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations, including general R&F and pediatric examinations.
    Category
    Distribution
    18 states
  • HighFDA (Devices)··2019-06-19

    GE Healthcare Recalls Silhouette VR Systems Due to Monitor Mount Failure

    GE Healthcare is recalling 825 Silhouette VR systems because a CRT monitor fell off its wall mount due to product aging.

    Product
    Silhouette VR This fully integrated system offers intuitive controls with advanced applications for maximum performance all in a space-saving design.
    Category
    Distribution
    18 states
  • HighFDA (Devices)··2019-06-19

    GE Healthcare Recalls Prestilix 1600X Digital Radiology Systems

    GE Healthcare is recalling 825 Prestilix 1600X digital radiology systems because a monitor fell off its wall mount due to product aging.

    Product
    Prestilix 1600X Prestilix system is a fully integrated remote controlled digital radiology system. It is designed for all general radiology applications with or without contract injection and interventional procedures.
    Category
    Distribution
    18 states
  • ModerateFDA (Devices)··2019-06-19

    GE Healthcare Recalls Prestige Systems Due to Monitor Mount Failure

    GE Healthcare is recalling Prestige II, SI, and VH systems because a CRT monitor fell off its wall mount due to product aging.

    Product
    Prestige II, Prestige SI, Prestige VH Prestige system is a new multi-purpose conventional and digital R/F remote controlled system.
    Category
    Distribution
    18 states
  • HighFDA (Devices)··2019-06-19

    GE Healthcare Recalls Proteus XR/a Radiographic Systems Due to Monitor Fall Risk

    GE Healthcare is recalling 825 Proteus XR/a radiographic systems because a monitor fell off its wall mount due to product aging.

    Product
    Proteus XR/a The Proteus XR/a radiographic system offers the flexibility to choose a configuration based upon your specific requirements. The system provides exceptional image quality, high frequency X-ray generation, easy patient positioning, intuitive operator control and m
    Category
    Distribution
    18 states