The Recall Desk

FDA (Devices) recall action 69474

GE OEC Medical Systems, Inc recalled 4 products on 2014-11-19

The FDA (Devices) publishes a recall like this one as 4 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 4 pages.

Products
4
Announced
2014-11-19
Critical
0
Units
344

Why these products were recalled

GE Healthcare initiated a field correction because prior revision of components were potentially installed on certain OEC 9800, FlexiView 8800, OEC MiniView 6800 and OEC UroView 2800 systems.

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.

1–4 of 4

  • ModerateFDA (Devices)··2014-11-19

    GE OEC MiniView 6800 C-Arm Recall for Component Revision

    GE Healthcare is recalling 26 OEC MiniView 6800 C-Arms because prior component revisions may have been incorrectly installed.

    Product
    OEC¿ MiniView 6800. The Mini 6800 Digital Mobile C-Arm is designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imaging. The device is not intended for whole-body pediatric…
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2014-11-19

    GE OEC UroView 2800 Imaging Systems Field Correction for Component Revision

    GE Healthcare is correcting OEC UroView 2800 systems because prior component revisions may have been incorrectly installed.

    Product
    OEC¿ UroView 2800. The UroView 2800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical. and interventional procedures
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2014-11-19

    GE Healthcare Recalls FlexiView 8800 Digital Mobile Imaging Systems

    GE Healthcare is recalling five FlexiView 8800 systems because prior component revisions were potentially installed on these units.

    Product
    FlexiView 8800 Digital Mobile Imaging System. The FlexiView 8800 Digital Mobile Imaging System is designed to provide fluoroscopic and spot film, imaging of the patient during diagnostic, surgical and interventional procedures.
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2014-11-19

    GE OEC 9800 Medical Imaging Systems Field Correction for Component Revision

    GE Healthcare is correcting 311 OEC 9800 imaging systems worldwide because prior component revisions may have been incorrectly installed.

    Product
    Series OEC 9800. The Series OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient,during diagnostic, surgical and interventional procedures.
    Category
    Distribution
    0 states