The Recall Desk

FDA (Devices) recall action 62404

GE OEC Medical Systems, Inc recalled 3 products on 2012-07-25

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
2012-07-25
Critical
0
Units
13,175

Why these products were recalled

Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues this recall is now being classified by the Agency. GE OEC recalled imaging devices OEC 9900, OEC 9800, and OEC 8800 as a result of an FDA inspection identifying that the vertical lift column power supply in the mainframe C-arm is defective and subject to early life 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.

1–3 of 3

  • HighFDA (Devices)··2012-07-25

    GE OEC 8800 Flexiview Imaging Device Recall for Defective Power Supply

    GE OEC Medical Systems is recalling OEC 8800 Flexiview imaging devices because an FDA inspection found a defective vertical lift column power supply subject to early life failure.

    Product
    OEC 8800 Flexiview designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The OEC 8800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and…
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2012-07-25

    GE OEC Motorized C-Arm Systems Recalled for Defective Power Supply

    GE OEC Medical Systems is recalling OEC 9800 series motorized C-arm systems because a defective vertical lift column power supply is subject to early life failure.

    Product
    OEC 9800, OEC FluoroTrak 9800 Plus, OEC 9800 Plus, OEC 9800 MD Motorized C-arm System designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The OEC 9800 is designed to provide fluoroscopic and…
    Category
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    0 states
  • HighFDA (Devices)··2012-07-25

    GE OEC 9900 Elite C-arm System Recalled for Power Supply Defect

    GE OEC recalled 726 OEC 9900 Elite C-arm systems worldwide due to a defective vertical lift column power supply identified during an FDA inspection.

    Product
    OEC 9900 Elite, OEC 9900 Elite MD Motorized C-arm System, OEC 9900 Elite NAV used as an aid to locate anatomical structures during open or percutaneous surgical procedures. The system is an aid to locate anatomical structures during open or percutaneous surgical procedures.…
    Category
    Distribution
    0 states