The Recall Desk

FDA (Devices) recall action 62449

GE OEC Medical Systems, Inc recalled 3 products on 2012-08-08

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
2012-08-08
Critical
0
Units
246

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 had discovered an issue with the hard disk drives that were installed on OEC device models: UroView 2800; 9800 Plus Digital; MiniView 6800; and FlexiView 8800 Mobile C-Arm. The devices were manufactured between October 15, 2004 and

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)··2012-08-08

    GE OEC Medical Systems Recalls OEC 9800 Plus Digital Imaging Systems

    GE OEC Medical Systems is recalling OEC 9800 Plus Digital imaging systems due to a hard disk drive issue. The recall covers 82 units distributed worldwide.

    Product
    OEC 9800 Plus Digital; MDL number A349855. Product Usage: Is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Clinical applications may include cholangiography, endoscopic, urologic, orthopedic…
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2012-08-08

    GE OEC Medical Systems Recalls UroView 2800 Imaging Devices

    GE OEC Medical Systems is recalling UroView 2800 and other imaging devices due to hard disk drive issues. The recall covers 82 units distributed worldwide.

    Product
    UroView 2800; MDL number A349855. Product Usage: Designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical, and interventional procedures. Clinical application may include but are not limited to urologic and endoscopic procedures. The…
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2012-08-08

    GE OEC Medical Systems Recalls Mobile C-Arm Devices for Hard Disk Drive Issue

    GE OEC Medical Systems is recalling OEC MiniView 6800 Mobile C-Arms due to a hard disk drive issue. The recall covers 82 units distributed worldwide.

    Product
    OEC MiniView 6800 Mobile; MDL number A349855. Product Usage: 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…
    Category
    Distribution
    0 states