The Recall Desk

FDA (Devices) recall action 76033

GE OEC Medical Systems, Inc recalled 3 products on 2017-01-18

The FDA (Devices) publishes a recall like this one as 3 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 3 pages.

Products
3
Announced
2017-01-18
Critical
0
Units
—

Why these products were recalled

GE Healthcare Surgery announces a voluntary field action for the OEC MiniView 6800, OEC 9900 Elite, and OEC 9800 because the workstation power cable assembly can result in intermittent power cord failures.

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

States named across these recalls

1–3 of 3

  • ModerateFDA (Devices)··2017-01-18

    GE OEC MiniView 6800 C-Arm Recalled for Power Cable Failures

    GE Healthcare is conducting a voluntary field action for OEC MiniView 6800, OEC 9900 Elite, and OEC 9800 devices due to intermittent power cord failures.

    Product
    OEC MiniView 6800. MDL Number: D002533 The OEC MiniView 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 wh
    Category
    Distribution
    50 states
  • ModerateFDA (Devices)··2017-01-18

    GE Healthcare Recalls OEC 9800 Imaging Systems Due to Power Cable Failures

    GE Healthcare is conducting a voluntary field action for OEC 9800 systems because the workstation power cable assembly can cause intermittent power cord failures.

    Product
    OEC 9800. MDL Numbers: D222250, D141598 The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic,
    Category
    Distribution
    50 states
  • ModerateFDA (Devices)··2017-01-18

    GE OEC Mobile Fluoroscopy Systems Recalled for Power Cable Failures

    GE Healthcare is recalling OEC 9900 Elite and other mobile fluoroscopy systems because the workstation power cable assembly can fail intermittently.

    Product
    The OEC 9900 Elite mobile fluoroscopy system is designed to provide fluoroscopic and spot-film images of the patient during diagnostic surgical and interventional procedure. Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic,
    Category
    Distribution
    50 states